Data / Medical devices / United States / Arvato Usa LLC
Arvato Usa LLC: FDA-registered device maker in Memphis, TN, United States, 228 510(k) clearances and 3 PMA approvals
Arvato Usa LLC is registered with the FDA (registration 3021008900) in Memphis, TN, United States. It lists 55 device types. The FDA files 228 510(k) clearances and 3 PMA approvals under its listings, the newest dated March 25, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021008900
- Address
- 3303 E Holmes Rd, Memphis, TN, United States, 38118
- Owner or operator
- Arvato USA LLC (10082727)
- Roles
- Repackager or relabeler
- First device listed
- September 23, 2021
- Registered through
- 2026
- Brand names listed
- Smith and Nephew
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 228.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 25, 2021 | K210566 | LEGION Porous CR Narrow Femoral Components | MBH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 31, 2019 | K191002 | OR3O Dual Mobility System | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 24, 2019 | K183346 | FLOW 90 Wand | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| May 1, 2018 | K180848 | AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| November 30, 2017 | K171934 | Birmingham Hip (BH) Dual Mobility Insert | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 17, 2017 | K172165 | Q-Fix Suture Anchor | MBI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| November 23, 2016 | K161264 | TRIGEN Low Profile Bone Screws | HSB | Substantially Equivalent | Smith & 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 |
| January 28, 2016 | K153186 | Adjustable Fixation Device | MBI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| October 23, 2015 | K143235 | RF20000a Controller, FLOW 50 Wand | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| April 20, 2015 | K143739 | POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA | LZO | Substantially Equivalent | Smith & Nephew, Inc. | 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 29, 2014 | K140555 | JOURNEY II BCS CONSTRAINED INSERTS | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 15, 2014 | K133662 | SMITH & NEPHEW CANNULATED CAPTURED SCREW | HWC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 7, 2014 | K140814 | EVOS MINI-FRAGMENT PLATING SYSTEM | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| February 4, 2014 | K132886 | SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM | HRS | Substantially Equivalent | Smith & Nephew, 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 |
| October 22, 2013 | K132435 | SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS | LZO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 10, 2013 | K130728 | POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA | LZO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 4, 2013 | K130748 | SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0 | OLO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 2, 2013 | K122652 | ARTHROCARE TURBINATOR WAND | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| June 28, 2013 | K123598 | SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION | JDI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 3, 2013 | K123159 | SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS | JWH | 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 14, 2013 | K123240 | SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT | MBI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| November 15, 2012 | K122011 | NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP | OLO | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| November 7, 2012 | K123268 | SMARTSTITCH PERFECTPASSER SYSTEM | GAT | Substantially Equivalent | Arthocare Corporation | accessdata.fda.gov |
| October 24, 2012 | K123012 | SMITH & NEPHEW SMF HIP STEM | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 19, 2012 | K122170 | SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION | HSB | Substantially Equivalent | Smith & Nephew, Inc. | 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 |
| October 16, 2012 | K122139 | SMITH & NEPHEW R3 CONSTRAINED LINERS | KWZ | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 15, 2012 | K121627 | SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM | MEH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 5, 2012 | K113039 | SMITH & NEPHEW RADIOPAQUE TRIAL NECKS | MEH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 7, 2012 | K121714 | SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS | HSD | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 28, 2012 | K122296 | SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING | LZO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 23, 2012 | K122244 | POLARCUP DUAL MOBILITY SYSTEM | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 13, 2012 | K121443 | JOURNEY II CR KNEE SYSTEM | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 7, 2012 | K121393 | SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION | MBH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 19, 2012 | K120211 | SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING | LZO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 7, 2012 | K120871 | SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION | JDW | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 18, 2012 | K120698 | GENESIS II PS NON-MODULAR FEMORAL COMPONENT | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 27, 2012 | K113848 | R3 XLPE LINERS | MBL | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 19, 2012 | K113789 | MODULAR PROXIMALLY FLUTED HIP STEM | MEH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 4, 2012 | K120667 | VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| February 27, 2012 | K113482 | JOURNEY II DEEP DISHED ARTICULAR INSERTS | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 5, 2012 | K113038 | SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS | HSX | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 20, 2011 | K112941 | LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTS | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 14, 2011 | K112406 | PERI-LOC PROXIMAL FEMUR LOCKING BONE PLATES | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 14, 2011 | K110135 | POLARCUP DUAL MOBILITY SYSTEM | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 11, 2011 | K111994 | SMITH & NEPHEW CANNULATED SCREWS AND WASHERS | HWC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 16, 2011 | K111711 | JOURNEY II BCS KNEE SYSTEM | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 9, 2011 | K111635 | SMITH & NEPHEW RJ CONSTRAINED LINERS | KWZ | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 12, 2011 | K110670 | VLP FOOT TALUS PLATES, VLP PERCUTANEOUS CALCANEUS PLATES AND MISC VLP BONE SCREWS, PERI-LOC ANKLE FUSION PLATES | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 1, 2011 | K111025 | TRIGEN LOW PROFILE BONE SCREW | HSB | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 22, 2011 | K110837 | REVISION PROTHESIS | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 14, 2011 | K110240 | SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1 | OLO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 11, 2011 | K110101 | TAPER OXINIUM FEMORAL HEAD | LZO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 4, 2011 | K102990 | BRAINLAB KNEE | OLO | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| February 8, 2011 | K110069 | SMITH & NEPHEW, INC SPATIALFRAME V4.1 WEB-BASED SOFTWARE | KTT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 31, 2011 | K103256 | SMITH & NEPHEW SMF HIP STEM | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 19, 2011 | K102370 | R3 XLPE ANTEVERTED LINERS | MBL | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 5, 2010 | K102069 | JOURNEY UNICONDYLAR TIBIAL BASEPLATES | HSX | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 27, 2010 | K093047 | SMITH & NEPHEW CIRCULAR FIXATION SYSTEM | KTT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 2, 2010 | K100795 | JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING | KTT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 26, 2010 | K101499 | JOURNEY CR KNEE SYSTEM | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 15, 2010 | K100481 | SMITH & NEPHEW MDF MODULAR SLEEVE | MEH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 13, 2010 | K100897 | LEGION POROUS + HA TIBIAL BASEPLATES | MBH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 13, 2010 | K100353 | SPINEWAND SURGICAL DEVICE | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| May 6, 2010 | K092467 | VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED | HAW | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| May 5, 2010 | K100412 | BIOLOX DELTA CERAMIC FEMORAL HEADS | LZO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 4, 2010 | K100325 | PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES | HWC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 26, 2010 | K092748 | SURESHOT TAN NAILS AND ACCESSORIES | HSB | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 21, 2010 | K090982 | SMITH & NEPHEW HIP SYSTEMS WITH HA | MEH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 14, 2010 | K093746 | VERILAST WEAR CLAIMS FOR THE LEGION PRIMARY KNEE SYSTEM | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 26, 2010 | K093363 | COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS | MBL | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 22, 2010 | K092098 | PATIENT SPECIFIC ACETABULAR RECONSTRUCTION PROSTHESIS | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 21, 2009 | K091543 | LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS | MBH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 15, 2009 | K093056 | SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM | NPJ | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 10, 2009 | K092002 | AFGHAN EXTERNAL FIXATOR | KTT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 3, 2009 | K092386 | R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS | MBL | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 29, 2009 | K091014 | JOURNEY BCS KNEE SYSTEM | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 11, 2009 | K092497 | SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.1 | OLO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 30, 2009 | K092015 | PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 8, 2009 | K090926 | SMITH & NEPHEW RAIL SYSTEM | KTT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 4, 2009 | K090675 | SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 3, 2009 | K090656 | INTERTAN CHS LIMITED COLLAPSE SET SCREW | HWC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 8, 2009 | K083483 | BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED | OLO | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| March 11, 2009 | K083762 | BIOLOX DELTA CERAMIC FEMORAL HEADS | LZO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 3, 2009 | K083566 | R3 CONSTRAINED LINER, CONSTRAINED LINER | KWZ | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 7, 2009 | K083032 | PERI-LOC BONE PLATING AND SCREW SYSTEM | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 10, 2008 | K083306 | MODIFICATION TO ARTHROCARE ARTHROWANDS | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| November 25, 2008 | K082358 | SMITH & NEPHEW, INC. PATIENT MATCHED TECHNOLOGY | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 17, 2008 | K082516 | PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS | HWC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 5, 2008 | K081016 | SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM | PHX | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 21, 2008 | K081566 | SMITH & NEPHEW OXINIUM DH FEMORAL HEADS | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 31, 2008 | K081124 | MDF REVISION HIP SYSTEM | MEH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 24, 2008 | K081351 | MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT | HSX | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 23, 2008 | K081111 | LEGION HINGE KNEE SYSTEM | KRO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 18, 2008 | K081106 | PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM VOLAR DISTAL RADIUS LOCKING PLATE FOR THE UPPER EXTREMITY-ASTM F139 | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 9, 2008 | K072852 | SL-PLUS STANDARD AND LATERAL HIP STEMS | LZO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| October 17, 2016 | P150030 | R3 DELTA CERAMIC HIP SYSTEM | MRA | 48 | April 17, 2025 | accessdata.fda.gov |
| May 9, 2006 | P040033 | BIRMINGHAM HIP RESURFACING (BHR) SYSTEM | NXT | 36 | January 10, 2025 | accessdata.fda.gov |
| December 17, 2004 | P030022 | REFLECTION CERAMIC ACETABULAR SYSTEM | MRA | 47 | August 8, 2022 | accessdata.fda.gov |
Compare with other makers
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- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- All makers of Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Updated April 17, 2025. 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.