Data / Medical devices / United States / Acumed LLC
Acumed LLC: FDA-registered device maker in Hillsboro, OR, United States, 76 510(k) clearances
Acumed LLC is registered with the FDA (registration 3025141) in Hillsboro, OR, United States. It lists 31 device types. The FDA files 76 510(k) clearances under its listings, the newest dated October 27, 2025. 22 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3025141
- FEI number
- 1000125930
- Address
- 5885 NE Cornelius Pass Rd, Hillsboro, OR, United States, 97124
- Owner or operator
- ACUMED LLC (9001805)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- March 8, 2004
- Registered through
- 2027
- Brand names listed
- ARC SURGICAL RESORBABLE, ARH Slide-Loc Radial Head Solutions, ARH Solutions, ARH Solutions 2, Acu Loc 2 System, Acu Loc System, Acu-Loc NEXT Wrist Fixation System. Acu-Loc(r) NEXT(TM), Acu-Sinch Knotless and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 27, 2025 | K250297 | TECHFIT Patient-Specific Cranial System | GWO | Substantially Equivalent | Techfit Digital Surgery, Inc. | accessdata.fda.gov |
| July 14, 2025 | K251132 | The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws | HRS | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| June 18, 2025 | K251296 | The Acumed Wrist Fixation System | HRS | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| January 23, 2025 | K243624 | Acu-Sinch Knotless Mini | HTN | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| December 11, 2024 | K242263 | TECHFIT DISRP® System | DZJ | Substantially Equivalent | Techfit Digital Surgery, Inc. | accessdata.fda.gov |
| April 22, 2024 | K233311 | Acumed Wrist Plating System | HRS | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| June 23, 2023 | K230276 | TECHFIT DISRP® System | DZJ | Substantially Equivalent | Techfit Digital Surgery | accessdata.fda.gov |
| June 9, 2023 | K230744 | Acumed Acutrak 3 Headless Compression Screw System | HWC | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| January 6, 2023 | K222577 | TECHFIT Diagnostic Models | LLZ | Substantially Equivalent | Techfit Digital Surgery, Inc. | accessdata.fda.gov |
| December 29, 2022 | K221333 | Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional | HWC | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| April 27, 2022 | K220892 | ExsoMed INnate NanoTM Lag Screw System | HWC | Substantially Equivalent | Exsomed Corp. | accessdata.fda.gov |
| January 7, 2022 | K212990 | Acumed Ankle Syndesmosis Repair System | HTN | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| July 15, 2021 | K210750 | Acumed Clavicle Hook Plating System | HRS | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| May 19, 2021 | K203282 | TECHFIT Patient-Specific Maxillofacial System | JEY | Substantially Equivalent | Industrias Medicas Sampedro S.A.S | accessdata.fda.gov |
| June 20, 2020 | K201430 | InFrame Cannulated Fixation System | HWC | Substantially Equivalent | Exsomed Corp. | accessdata.fda.gov |
| December 3, 2019 | K192473 | Exsomed Wrist Plating System | HRS | Substantially Equivalent | Exsomed Corporation | accessdata.fda.gov |
| March 12, 2019 | K183603 | INnate Cannulated Screw System | HWC | Substantially Equivalent | Exsomed Corporation | accessdata.fda.gov |
| September 1, 2017 | K171558 | ExsoMed ITN Cannulated Screw System | HWC | Substantially Equivalent | Exsomed Holdings Company, LLC | accessdata.fda.gov |
| August 18, 2017 | K171407 | ExsoMed ArcPhix and ExsoMed ArrowPhix | HWC | Substantially Equivalent | Exsomed Holding Company, LLC | accessdata.fda.gov |
| October 30, 2015 | K151886 | Acumed Ankle and Small Fragment Base Set Update | HRS | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| April 6, 2015 | K143385 | Acumed Ankle Plating System | HRS | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| February 5, 2015 | K143276 | Acumed Small Bone IM Nail System | HSB | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| January 23, 2015 | K143394 | Acumed Small Fragment Base Set | HRS | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| June 13, 2014 | K141383 | ACUMED HAND FRACTURE SYSTEM | HRS | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| May 20, 2014 | K140925 | ACUMED SUTURE ANCHOR SYSTEM | MBI | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| March 10, 2014 | K133469 | ACUMED SUTURE ANCHOR SYSTEM | MBI | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| October 10, 2013 | K131636 | POLARUS CONNECT | LXT | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| September 30, 2013 | K131845 | ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC | KWI | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| September 5, 2013 | K131764 | ACUMED WRIST SPANNING PLATE | HRS | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| July 23, 2013 | K130986 | FRAG-LOC SYSTEM | HTN | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| June 10, 2013 | K131380 | ACUMED TOTALW RIST FUSION PLATING SYSTEM | HRS | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| March 18, 2013 | K123890 | ACUMED CANNULATED SCREW SYSTEM | HWC | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| November 19, 2012 | K122538 | ACUMED PELVIC BONE PLATE SYSTEM | HRS | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| July 13, 2012 | K120903 | CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE | HRS | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| February 17, 2012 | K120163 | ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM | HRS | Substantially Equivalent | Acute Innovations, LLC | accessdata.fda.gov |
| January 12, 2012 | K113318 | ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM | HRS | Substantially Equivalent | Acute Innovations, LLC | accessdata.fda.gov |
| November 14, 2011 | K112111 | ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR | HTN | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| October 24, 2011 | K102387 | MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIES | JDR | Substantially Equivalent | Mediscope Manufacturing, Inc. | accessdata.fda.gov |
| August 29, 2011 | K111608 | SLIC SCREW REPAIR SYSTEM | HWC | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| October 6, 2010 | K100123 | ACUMED WRIST ARTHRODESIS PLATE SYSTEM | HRS | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| September 17, 2010 | K101170 | ACUTE INNOVATIONS STERNAL FIXATION SYSTEM | KTT | Substantially Equivalent | Acute Innovations, LLC | accessdata.fda.gov |
| June 16, 2009 | K083144 | ACUMED CLAVICLE SCREW SYSTEM | JDW | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| December 19, 2007 | K071616 | ARC SURGICAL BIOTRAK PIN SYSTEM | HTY | Substantially Equivalent | Arc Surgical, LLC | accessdata.fda.gov |
| July 18, 2007 | K071715 | ACUMED CONGRUENT BONE PLATE SYSTEM | HRS | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| December 27, 2006 | K063244 | ARC SURGICAL BONE REDUCTION SCREW | HWC | Substantially Equivalent | Arc Surgical, LLC | accessdata.fda.gov |
| September 19, 2006 | K061763 | ARC SURGICAL BIOTRAK SCREW | HWC | Substantially Equivalent | Arc Surgical, LLC | accessdata.fda.gov |
| June 17, 2005 | K043176 | ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM | HWC | Substantially Equivalent | Arc Surgical, LLC | accessdata.fda.gov |
| May 12, 2005 | K051083 | ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM | HRS | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| October 5, 2004 | K041858 | ACUMED ANATOMIC RADIAL HEAD SYSTEM | KWI | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| January 15, 2004 | K033639 | ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM | HWC | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| July 17, 2003 | K031438 | ACUMED SMALL BONE LOCKING ROD SYSTEM II | HSB | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| July 17, 2002 | K021321 | WRIST FUSION PLATE | HRS | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| December 19, 2001 | K013616 | POLARUS CAP SCREW | HSB | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| November 7, 2001 | K012655 | CONGRUENT BONE PLATE SYSTEM | HRS | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| February 4, 2000 | K992525 | ACUMED MODULAR SHOULDER SYSTEM | HSD | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| March 16, 1998 | K980103 | ACUMED SUTURE ANCHOR | MBI | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| February 19, 1997 | K965029 | STABLELOC II EXTERNAL FIXATOR | JEC | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| December 9, 1996 | K964500 | ACUMED TENSION BAND PIN | HTY | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| October 10, 1996 | K963118 | EXTREMITY BONE SCREW | HWC | Substantially Equivalent for Some Indications | Acu Med, Inc. | accessdata.fda.gov |
| May 7, 1996 | K960711 | ACUMED BONE GRAFT SYSTEM | KIJ | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| October 5, 1995 | K952330 | EXTERNAL FIXATOR | JEC | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| August 11, 1995 | K951740 | INTRAMEDULARY FIXATION ROD | HSB | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| July 6, 1995 | K951673 | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | HSB | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| May 5, 1995 | K944330 | ACUTRAK PLUS FIXATION SYSTEM | HWC | Substantially Equivalent for Some Indications | Acu Med, Inc. | accessdata.fda.gov |
| April 13, 1995 | K942359 | BONE PLATE SYSTEM | HRS | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| January 27, 1995 | K943857 | EXTERNAL FIXATOR | JEC | Substantially Equivalent for Some Indications | Acu Med, Inc. | accessdata.fda.gov |
| December 5, 1994 | K942341 | CANNULATED CANCELLOUS BONE SCREW | HWC | Substantially Equivalent for Some Indications | Acu Med, Inc. | accessdata.fda.gov |
| December 5, 1994 | K942340 | CORTICAL BONE SCREW | HWC | Substantially Equivalent for Some Indications | Acu Med, Inc. | accessdata.fda.gov |
| November 9, 1994 | K942603 | ORTHOPAEDIC WIRES | LRN | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| February 22, 1994 | K933361 | ACUMED RADIUS ROD | HSB | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| February 22, 1994 | K931246 | CERCLAGE WIRE CRIMP SLEEVE | JDQ | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| February 15, 1994 | K931244 | BONE PLATE | HRS | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| July 26, 1993 | K930834 | ACUTRACT | HWC | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| August 5, 1992 | K920666 | INTRAMEDULARY FIXATION ROD | HSB | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| June 26, 1992 | K921480 | OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM | JDQ | Substantially Equivalent | Acu-Med, Inc. | accessdata.fda.gov |
| February 13, 1992 | K915613 | BONE SCREW 3.5 MM | HWC | Substantially Equivalent for Some Indications | Acu Med, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 28, 2026 | 99123 | Class II | Ongoing | Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw; 3070-27009 2.7mm x 9mm NL Hexalobe Screw; 3070-27010 2.7mm x 10mm NL Hexalobe Screw; 3070-27011 2.7mm x 11mm NL Hexalobe Screw; | Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use. | accessdata.fda.gov |
| December 19, 2023 | 93878 | Class II | Ongoing | Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Left; 70-0045-S Acu-Loc VDU Plate Standard, Left; 70-0046 Acu-Loc VDU Plate Standard, Right; 70-0046-S | Distribution without Pre-Market Clearance | accessdata.fda.gov |
| November 27, 2023 | 93470 | Class II | Ongoing | RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary Guide is an instrument used with a power system to compress the RibLoc plates onto the bone, determine the length o | Due to potential breakage during use. | accessdata.fda.gov |
| November 29, 2022 | 90996 | Class II | Ongoing | Part Number/Part Description: 30-0033-S 30mm Acutrak Fusion Device 6mm Nose AM-0025-S 25.0mm Acutrak 4/5 Bone Screw AM-0030-S 30.0mm Acutrak 4/5 Bone Screw AM-0035-S 35.0mm Acutrak 4/5 Bone Screw AM-0040-S 40.0mm Acutrak | Distribution without Pre-Market Clearance | accessdata.fda.gov |
| March 9, 2022 | 89771 | Class II | Completed | 4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010 | Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or damage, or soft tissue damage. | accessdata.fda.gov |
| April 20, 2017 | 77115 | Class II | Terminated | The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device is to be implanted by the surgeon in a sterile operating room setting. Implants are provided in steril | The firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Head System based on its performance in the market. The firm received product complaints regarding instrumentation performance, trial product design, and implant dissociations. | accessdata.fda.gov |
| February 17, 2017 | 76562 | Class II | Terminated | .045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diameter..054 X 7 ST Guide Wire, Part number 45-0031-S, Sterile 10 Pack of WS-1407ST and has a 7 inch len | Guide wires sized as.045 X 6 were mis-packaged as.054 X 7 guide wires and those sized as.054 X 7 were mis- packaged as.045 X 6 guide wires. There is a possibility that using the incorrect guide wire size can cause health hazards, such as mal or nonunion, need for revision surgery, and histological response (if wire breaks). | accessdata.fda.gov |
| January 19, 2017 | 76332 | Class II | Terminated | 6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates with varying lengths that function as internal fixation devices for fractures, fusions and osteotomies of the p | The 6-hole Pubic Symphysis plate (PN 70-0451) is specified to be made of Commercially Pure Titanium (ASTM F67 - CP Grade 4). However, batch 383813 was manufactured out of Titanium Alloy (Ti-6Al- 4V ELI per ASTM F135 Ti alloy) and was distributed. | accessdata.fda.gov |
| December 5, 2016 | 75904 | Class II | Terminated | OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium phosphate. The tricalcium phosphate is a soluble calcium phosphate salt. | OPT Croutons, part number 65-0210-S, is recalled due to the result of inadequate documentation of the sterilization dose used in production. Product sterilized at the site did not receive the minimum dose required per the new performance qualification. | accessdata.fda.gov |
| March 26, 2014 | 67885 | Class II | Terminated | The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates.. 2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S 2.0 mm SS Sleeve Only; Part Number 01-0022-S 8, 7 hole, SS compression plate | Manufacturing of these devices with a grade of stainless steel that is not within specifications. | accessdata.fda.gov |
| March 7, 2012 | 61333 | Not yet classified | Terminated | The Polarus Plus Humeral Rod (part number HR-0824-S) is intended as an intramedullary fixation device for humeral fractures. It is sealed in an internal sterile blister pack within a box that is labeled in part: "Polarus | The packaging contains the wrong product. It does not contain model HR-0824-S as the package indicates. | accessdata.fda.gov |
| April 14, 2010 | 55410 | Not yet classified | Terminated | Ulnar Shorting Saw Blade is labeled in part: "Congruent Bone Plates, SIZE Ulnar Shortening Saw Blade - Hub Style S, REF 80-0499-S, Material: Stainless Steel, STERILE, Rx Only, ACUMED, Hillsboro, OR, USA". The Ulnar Saw B | The saw blades may not cut aggressively enough for their intended application therefore creating a risk that the saw could generate excessive heat, which may contribute to bone necrosis and/or non-union. | accessdata.fda.gov |
| August 21, 2009 | 53163 | Not yet classified | Terminated | Biotrak PLLA Pin, Resorbable Fixation System, Biotrak 20 mm Pin; sterile pin packaged in sterile bag, enclosed within a box labeled Biotrak Resorbable Fixation System Biotrak 20 mm Pin REF 30170320-S Manufactured or Dist | Labeling may contain 2 lot numbers and 2 model numbers. It was observed that the box top label (30170060-S, W67391) does not match the two side labels (3010320-S, W67385). The part and patient labeling inside the box match the side labels (30170320-S, W67385). | accessdata.fda.gov |
| May 19, 2009 | 55184 | Not yet classified | Terminated | Polarus(R) Humeral Fixation System, size: 3.5mm x 25.0mm Cortical Screw, QTY 1, Ref: HCO3250-S Acumed, LLC Hillsboro, OR Intended use: Acumed intramedullary rods and screws are designed to provide fixation of humeral, fo | Mix-up of parts - Product labeled cortical bone screw actually contains Acutract fixation screw | accessdata.fda.gov |
| August 21, 2008 | 49383 | Not yet classified | Terminated | Intramedullary Fixation Rod, common name Fibula Rod, labeled IM Rod System Manufactured or Distributed by: ACUMED Hillsboro, OR | Products improperly handled after cleaning, prior to sanitation and may be contaminated with inorganic material. | accessdata.fda.gov |
| July 9, 2008 | 48976 | Not yet classified | Terminated | Stableloc (TM) Wrist External Fixation System, Quantity 1. Packaged labeled, "Stableloc Wrist Fixator System... Desc:stabeloc (TM) External Fixator Kit... Ref FX-4001-S... Manufactured or Distributed by: Acumed (R) 5885 | Parts are non-functional. The user is unable to fully pass the fixator pins through the body of the Stableloc assembly as required. The kit may also be missing the set screw. | accessdata.fda.gov |
| May 13, 2008 | 48470 | Not yet classified | Terminated | Modular Shoulder Body Assembly, Left (SH-1540L-S) and Modular Shoulder Body Assembly, Right (SH-1540R-S). Product labeled in part, "Acumed 5885 NW Cornelius Pass Road Hillsboro, OR 97124-9432 " | The packages for Modular Shoulder Body Assembly Left (SH-1540L-S) and Modular Shoulder Body Assembly Right (SH-1540R-S) may contain assemblies for the opposite side as indicated. | accessdata.fda.gov |
| March 28, 2008 | 48465 | Not yet classified | Terminated | Osteo-Clage Cable System Package Assembly (01-0001-S). Product labeled in part, "2.0mm x 850 mm CoCr Cable / Sleeve... REF 01-0001-S LOT W59192... Acumed 5885 NW Cornelius Pass Road Hilsboro, OR 97124-9432 ". | Cables of incorrect diameter were used in product assembly, resulting in the sleeve not being able to bind to the cable after crimping. | accessdata.fda.gov |
| February 14, 2008 | 48453 | Not yet classified | Terminated | 5 Hole Locking 1st Tarsometatarsal Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: 5 Hole Locking 1st Tarsometatarsal Plate... REF 70-0007-S... LOT W58115". | Product sterility may be compromised. | accessdata.fda.gov |
| July 9, 2007 | 48457 | Not yet classified | Terminated | Smooth or threaded metallic bone fixation fastener. 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in part, "Congruent Plate System... Size: 3.5mm x 14. | Product mislabeled. The inner sticky labels for the patient identified the product incorrectly as a Cortical screw (non-locking). The product package was labeled correctly. | accessdata.fda.gov |
| June 29, 2007 | 48466 | Not yet classified | Terminated | Acu-Loc Distal Radius Plate, Standard, Left. Product labeled in part, " Acu-Loc Distal Radius Plate, Standard, Left... PL-DR50L W48003... Manufactured or Distributed by: Acumed LLC Hillsboro, OR ". | Plates are incorrectly laser marked. The PL-DR50L plates are incorrectly laser marked with PL-DR70L. | accessdata.fda.gov |
| December 27, 2005 | 48468 | Not yet classified | Terminated | 3.5mm X 32.5mm Cortical Screw used with the Polarus Humeral Fixation System,. Product labeled in part, "Polarus Humeral Fixation System& SIZE: 3.5mm X 32.5mm Cortical Screw... REF HCO3325-S... Acumed 5885 NW Cornelius Pa | Package of 3.5mm X 32.5mm cortical screw may contain 3.5mm X 22.5mm cortical screw. | accessdata.fda.gov |
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Updated June 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.