Data / Medical devices / Costa Rica / Arthrocare Corporation
Arthrocare Corporation: FDA-registered device maker in Coyol Alajuela, Costa Rica, 132 510(k) clearances
Arthrocare Corporation is registered with the FDA (registration 3012358417) in Coyol Alajuela, Costa Rica. It lists 42 device types. The FDA files 132 510(k) clearances under its listings, the newest dated July 9, 2026. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3012358417
- Address
- B32.1, St2 Zona Franca Coyol, Coyol Alajuela, Costa Rica, 20101
- Owner or operator
- Smith & Nephew, Inc. (1020279)
- Roles
- Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler
- First device listed
- February 22, 1978
- Registered through
- 2027
- Brand names listed
- "BIORAPTOR KNOTLESS SUTURE ANCHOR, SHOULDER CLOSE", (6) MINITAPE (BLUE) 39.5, (6) MINITAPE (COBRAID BLUE) 39.5, (6) MINITAPE (COBRAID WHITE) 39.5, 1.2 ENDOBUTTON CL ULTRA PAC, 1.2 RAP-PAC A LATEX FREE, 1.2 RAP-PAC A, 72202796, 1.2 RAP-PAC B LATEX FREE 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. Newest 100 of 132.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 9, 2026 | K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982) | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 30, 2026 | K254122 | FLOW FLEXTEND Wand (72290039) | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| March 25, 2026 | K253680 | LYNX COBLATION Laryngeal Wand (72290254) | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| June 25, 2025 | K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue) | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 26, 2024 | K242631 | REGENETEN Bioinductive Implant | OWY | Substantially Equivalent | Smith & Nephew Inc., Endoscopy Div. | accessdata.fda.gov |
| June 20, 2024 | K241435 | Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 8, 2024 | K240964 | FLOW 90? Wand | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| January 17, 2024 | K233730 | Footprint Mini PK, 3.5mm Suture Anchor | MBI | Substantially Equivalent | Smith & Nephew | accessdata.fda.gov |
| September 8, 2023 | K232457 | Q-FIX ULTRA All-Suture Anchor | MBI | Substantially Equivalent | Smith & Nephew | accessdata.fda.gov |
| August 9, 2023 | K231376 | Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape) | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 4, 2023 | K232005 | HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid) | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 26, 2023 | K230914 | ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146) | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| May 11, 2023 | K222501 | Regeneten Bioinductive Implant | OWY | Substantially Equivalent | Smith and Nephew, Inc. | accessdata.fda.gov |
| February 17, 2023 | K222971 | ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 1, 2022 | K220563 | Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| December 14, 2021 | K203716 | PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System | QFC | Substantially Equivalent | Smith and Nephew Medical Limited | accessdata.fda.gov |
| June 24, 2021 | K210423 | Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| February 1, 2021 | K203393 | FAST-FIX FLEX | GAT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 18, 2020 | K202006 | ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| March 18, 2020 | K193558 | HEALICOIL Knotless Suture Anchors | MAI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 20, 2019 | K192027 | WEREWOLF COBLATION System, COBLATION HALO Wand | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| January 24, 2019 | K183346 | FLOW 90 Wand | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| September 28, 2018 | K181746 | MICRORAPTOR Knotless Suture Anchor | MAI | Substantially Equivalent | Smith and Nephew, Inc. | accessdata.fda.gov |
| August 1, 2018 | K181772 | NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0) | GAT | Substantially Equivalent | Ceterix Orthopaedics, Inc. | accessdata.fda.gov |
| May 30, 2018 | K180361 | MICRORAPTOR REGENESORB Suture Anchor | MAI | Substantially Equivalent | Smith and Nephew, Inc. | accessdata.fda.gov |
| May 1, 2018 | K180848 | AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| March 29, 2018 | K180531 | NovoStitch Pro Meniscal Repair System | GAT | Substantially Equivalent | Ceterix Orthopaedics, Inc. | accessdata.fda.gov |
| August 17, 2017 | K172165 | Q-Fix Suture Anchor | MBI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| June 8, 2017 | K162996 | INVISIKNOT Ankle Syndesmosis Repair Kit | HTN | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 6, 2017 | K163142 | SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader | GAT | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| December 7, 2016 | K163034 | SUTUREFIX Curved Suture Anchor | MBI | Substantially Equivalent | Smith and Nephew, Inc. | accessdata.fda.gov |
| October 21, 2016 | K161481 | Ambient HipVac 50 Wand with Integrated Finger Switches | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| September 29, 2016 | K162126 | Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW) | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| August 22, 2016 | K162074 | Werewolf RF20000 Controller, FLOW 50 Wand | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| January 28, 2016 | K153186 | Adjustable Fixation Device | MBI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| January 19, 2016 | K153669 | MultiFIX S Ultra Knotless Fixation System | MBI | Substantially Equivalent | Arthocare Corporation | accessdata.fda.gov |
| January 15, 2016 | K153675 | Paragon T2 Wand with Integrated Cable | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| December 11, 2015 | K153313 | SpeedLock Knotless Fixation System | MBI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| December 2, 2015 | K152566 | PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 23, 2015 | K143235 | RF20000a Controller, FLOW 50 Wand | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| August 6, 2015 | K151897 | MultiFIX® P Knotless Fixation Device | MBI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| July 28, 2015 | K151105 | Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteoraptor Suture Anchor, Smith and Nephew Suture Anchors - Twinfix Ultra HA Suture Anchor, Smith and Nephew Suture Anchors - OSTEORAPTOR Curved Suture Anchors, Smith and Nephew Suture Anchors - Ultra Fast-Fix Meniscal Repair System, Ultra Fa | MAI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 19, 2014 | K142999 | EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| June 16, 2014 | K140992 | ARTHROCARE NASASTENT CMC NASAL DRESSING | LYA | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| June 10, 2014 | K140521 | TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGER SWITCH | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| May 14, 2014 | K140604 | MULTIFIX S KNOTLESS FIXATION SYSTEM | MBI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| March 26, 2014 | K140300 | COLLAGEN TENDON SHEET-DDI (CTS-DDI) | OWY | Substantially Equivalent | Rotation Medical, Inc. | accessdata.fda.gov |
| January 16, 2014 | K133727 | Q-FIX SUTURE ANCHOR, 1.8MM; Q-FIX SUTURE ANCHOR, 2.8MM; DRILL, DRILL GUIDE AND OBTURATOR, 1.8MM & 2.8MM, FIRSTPASS SUTU | MBI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| December 5, 2013 | K132079 | TFCC FAST-FIX KIT | GAT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 30, 2013 | K132357 | SMITH & NEPHEW ULTRATAPE | GAT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 29, 2013 | K131635 | ROTATION MEDICAL BONE STAPLE (RMB STAPLE) | MBI | Substantially Equivalent | Rotation Medical, Inc. | accessdata.fda.gov |
| August 9, 2013 | K131205 | ARTHROCARE HEAD AND NECK COBLATION WAND | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| July 2, 2013 | K122652 | ARTHROCARE TURBINATOR WAND | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| April 11, 2013 | K123393 | HEALICOIL SUTURE ANCHOR WITH REGENESORB | MAI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 18, 2013 | K122059 | ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| February 27, 2013 | K130196 | SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR | MBI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| February 20, 2013 | K123425 | TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| February 14, 2013 | K123240 | SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT | MBI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| January 23, 2013 | K123579 | FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 8, 2013 | K122048 | COLLAGEN TENDON SHEET-D | FTM | Substantially Equivalent | Rotation Medical, Inc. | accessdata.fda.gov |
| November 7, 2012 | K123268 | SMARTSTITCH PERFECTPASSER SYSTEM | GAT | Substantially Equivalent | Arthocare Corporation | accessdata.fda.gov |
| October 18, 2012 | K121861 | SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N | GAT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 12, 2012 | K121306 | SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE | GAT | Substantially Equivalent | Arthocare Corporation | accessdata.fda.gov |
| March 27, 2012 | K120096 | MULTIFIX P KNOTLESS FIXATION DEVICE | MBI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| January 20, 2012 | K113294 | SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 8, 2011 | K101377 | SMITH & NEWPHEW ULTRABRAID II SUTURE | GAT | Substantially Equivalent | Smith & Newphew, Inc. | accessdata.fda.gov |
| January 5, 2011 | K102982 | ENDOBUTTON DIRECT | MAI | Substantially Equivalent | Smith & Nephew Inc., Endoscopy Division | accessdata.fda.gov |
| December 13, 2010 | K102660 | BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS | MBI | Substantially Equivalent | Smith & Nephew Endoscopy, Inc. | accessdata.fda.gov |
| October 29, 2010 | K101437 | SPEEDFIX SUTURE SYSTEM | MBI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| June 21, 2010 | K101448 | OPUS SPEEDSCREW SYSTEM | MBI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| April 19, 2010 | K100159 | SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR | MBI | Substantially Equivalent | Smith & Nephew Inc., Endoscopy Div. | accessdata.fda.gov |
| March 4, 2010 | K093897 | SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR | MBI | Substantially Equivalent | Smith & Nephew Inc., Endoscopy Div. | accessdata.fda.gov |
| January 28, 2010 | K092508 | FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT, | GAT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 17, 2009 | K093428 | SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR | MBI | Substantially Equivalent | Smith & Nephew Endoscopy, Inc. | accessdata.fda.gov |
| December 15, 2009 | K093228 | SMITH & NEPHEW TWINFIX ULTRA PK SUTURE ANCHOR | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 4, 2009 | K093165 | ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| June 23, 2009 | K090393 | ARTHROCARE SYSTEM 15000 CONTOLLER, MODEL 72202149, ARTHROCARE ARTHROWANDS, MODEL 72202139,72202141, 72202143, 72202144 | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| June 17, 2009 | K091503 | MAGNUM MP FIXATION DEVICE | MBI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| January 30, 2009 | K083226 | SMITH & NEPHEW PEEK INTERFERENCE SCREW | MBI | Substantially Equivalent | Smith & Nephew Endoscopy, Inc. | accessdata.fda.gov |
| December 10, 2008 | K083306 | MODIFICATION TO ARTHROCARE ARTHROWANDS | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| October 1, 2008 | K081893 | OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500 | HWC | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| August 26, 2008 | K081511 | 2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 28, 2008 | K081497 | OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503) | MBI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| February 15, 2008 | K080282 | ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00; | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| September 18, 2007 | K072322 | ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS | GAT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 17, 2007 | K071586 | BIORAPTOR 2.3 PK SUTURE ANCHOR | MBI | Substantially Equivalent | Smith & Nephew Inc., Endoscopy Division | accessdata.fda.gov |
| April 25, 2007 | K070374 | ARTHROCARE ENT PLASMA WAND | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| April 16, 2007 | K070227 | OPUS MAGNUM PI KNOTLESS FIXATION DEVICE | MBI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| April 12, 2007 | K070167 | ENDOBUTTON DIRECT | MBI | Substantially Equivalent | Smith & Nephew Inc., Endoscopy Division | accessdata.fda.gov |
| April 2, 2007 | K070673 | FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTURE | GAT | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| October 2, 2006 | K062244 | OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR | OCW | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| October 21, 2005 | K052652 | SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE | GAT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 14, 2004 | K042584 | OPUS MINIMAGNUM ANCHOR WITH INSERTER | HWC | Substantially Equivalent | Opus Medical, Inc. | accessdata.fda.gov |
| November 12, 2004 | K042914 | OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE | MBI | Substantially Equivalent | Opus Medical, Inc. | accessdata.fda.gov |
| October 19, 2004 | K042031 | OPUS SPEEDSTITCH SUTURE DEVICE | GAT | Substantially Equivalent | Opus Medical, Inc. | accessdata.fda.gov |
| August 19, 2004 | K040542 | SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW | HWC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 14, 2004 | K040331 | SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS | HWC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 28, 2003 | K033584 | ARTHROCARE ARTHROWANDS | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| August 21, 2003 | K032504 | ARTHROCARE SYSTEM | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| August 8, 2003 | K032197 | TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 7210212 | MAI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Arthroscope
- All makers of Instrument, Special Lens, For Endoscope
- All makers of Screw, Fixation, Bone
- All makers of Suture, Nonabsorbable, Synthetic, Polyethylene
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated July 9, 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.