Platelet And Plasma Separator For Bone Graft Handling
Arthrex, Inc.
ARTHREX, INC.
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1220246 | 1220246 | ARTHREX, INC. | 1 | N | 2026-01-01 | 1370 Creekside Blvd Naples FL US 34108 |
| 3010331645 | 3010331645 | Arthrex, Inc. | 1 | N | 2026-01-01 | 6875 Arthrex Commerce Drive Ave Maria FL US 34142 |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 1476 | 1213657564 | K991971 | ARTHREX CHONDRAL DART, MODEL AR-4005B-18 | HTY | 2000-08-04 |
| 159366 | 1213657564 | K991971 | ARTHREX CHONDRAL DART, MODEL AR-4005B-18 | HTY | 2000-08-04 |
| 1476 | 1172069684 | K990987 | BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B | MAI | 2000-01-13 |
| 159366 | 1172069684 | K990987 | BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B | MAI | 2000-01-13 |
| 1476 | 1496666919 | K983843 | BIO-BUTTON 6.5MM, BIO-BUTTON 8MM, MODEL #'S AR-2236B & AR-2238B | MAI | 1999-03-12 |
| 159366 | 1526523718 | K983577 | ARTHREX MENISCAL DART SYSTEM | MAI | 1999-08-13 |
| 1476 | 1526523718 | K983577 | ARTHREX MENISCAL DART SYSTEM | MAI | 1999-08-13 |
| 1476 | 1415905884 | K982743 | DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER, MODEL #'S SB 313 PB, SB 313 PBH | GEI | 1998-09-14 |
| 1476 | 1329191466 | K981187 | ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001 | HWC | 1998-07-01 |
| 159366 | 1329191466 | K981187 | ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001 | HWC | 1998-07-01 |
| 1476 | 1803359182 | K974847 | 5.0MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22255, 3.5MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22235 | MBI | 1998-08-06 |
| 159366 | 1803359182 | K974847 | 5.0MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22255, 3.5MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22235 | MBI | 1998-08-06 |
| 1476 | 1312915195 | K973812 | ARTHREX PUDDU OSTEOTOMY SYSTEM | HRS | 1998-06-10 |
| 1476 | 1196806715 | K971723 | FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM) | MBI | 1997-07-30 |
| 1476 | 1232689819 | K971358 | BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM | MAI | 1997-07-09 |
| 159366 | 1232689819 | K971358 | BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM | MAI | 1997-07-09 |
| 1476 | 1201265194 | K961228 | KARL STORZ MAGNIFYING ARTHROSOCPES | HRX | 1996-10-10 |
| 159366 | 1753137371 | K960516 | FASTAK SUTURE ANCHOR | MBI | 1996-04-18 |
| 1476 | 1753137371 | K960516 | FASTAK SUTURE ANCHOR | MBI | 1996-04-18 |
| 159366 | 1645285625 | K945426 | ARTHREX CANCELLOUS SCREW AND WASHER | HWC | 1995-04-14 |
| 1476 | 1645285625 | K945426 | ARTHREX CANCELLOUS SCREW AND WASHER | HWC | 1995-04-14 |
| 1476 | 1440578319 | K945303 | ARTHREX BIOABSORBABLE INTERFERENCE SCREW | HWC | 1996-01-25 |
| 159366 | 1440578319 | K945303 | ARTHREX BIOABSORBABLE INTERFERENCE SCREW | HWC | 1996-01-25 |
| 1476 | 1370672514 | K943492 | ARTHREX STAPLES | JDR | 1995-02-01 |
| 1476 | 1508377083 | K943154 | KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHS | HRX | 1994-12-06 |
| 1476 | 1943372863 | K941541 | HSV LAPAROSCOPY SET | GCJ | 1994-05-16 |
| 1476 | 1044046155 | K934327 | ARTHREX SUTURE ANCHOR SCREW SYSTEM | MBI | 1995-09-15 |
| 159366 | 1044046155 | K934327 | ARTHREX SUTURE ANCHOR SCREW SYSTEM | MBI | 1995-09-15 |
| 1476 | 1635148370 | K932699 | ARTHREX AR-8200 SHAVER SYSTEM | HWE | 1994-01-25 |
| 1476 | 1173826867 | K921119 | ARTHREX ARTHROSCOPE | HRX | 1994-04-15 |
| 1476 | 1512532981 | K915721 | MODEL AR-6300 INFUSION PUMP | HRX | 1992-03-19 |
| 1476 | 1666311898 | K915424 | ARTHREX CANNULATED INTERFERENCE SCREW | HWC | 1993-02-09 |
| 1476 | 1235537325 | K901035 | FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE | FST | 1990-04-23 |
| 1476 | 1686459874 | K792558 | CONTAINER SYSTEM | FLE | 1979-12-27 |
| 1476 | 1475185656 | K260561 | Arthrex FiberTak Suture Anchor | MBI | 2026-03-20 |
| 1476 | 1266309140 | K260405 | FiberTape Button | MBI | 2026-03-09 |
| 1476 | 2018240914 | K260353 | Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button | HRS | 2026-03-03 |
| 1476 | 1364170554 | K254229 | Arthrex Nano FiberTak Suture Anchor | MBI | 2026-03-02 |
| 1476 | 1099428066 | K254215 | Arthrex Beaming System | HWC | 2026-05-08 |
| 1476 | 1573817328 | K253931 | |||
| 1476 | 1974207204 | K253895 | Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm | MBI | 2025-12-30 |
| 1476 | 1735370218 | K253727 | Syndesmosis TightRope PRO | HTN | 2025-12-22 |
| 1476 | 1737554326 | K253713 | Arthrex Variable Angle (VA) Proximal Tibia Plating System | HRS | 2026-01-21 |
| 1476 | 1047719926 | K252807 | Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates | HRS | 2026-01-12 |
| 1476 | 1963558779 | K252314 | Arthrex SutureTak Suture Anchor | MBI | 2025-10-29 |
| 1476 | 2043741607 | K252196 | Arthrex FibuLock Nail System | HSB | 2026-03-05 |
| 1476 | 1015326767 | K252016 | Arthrex Humeral Nails | HSB | 2026-03-20 |
| 1476 | 2058591559 | K251994 | Arthrex Synergy Vision Imaging System | GCJ | 2025-10-16 |
| 1476 | 1970689577 | K251809 | Arthrex FiberTak Suture Anchor | MBI | 2025-07-18 |
| 1476 | 1375106784 | K251690 | Arthrex SpeedFLEX Implant | OWY | 2025-09-30 |
| 1476 | 1485789776 | K251453 | Arthrex iBalance Partial Knee System | HSX | 2025-07-01 |
| 1476 | 1637067192 | K251145 | Arthrex PushLock Suture Anchors | MBI | 2025-07-10 |
| 1476 | 1786842472 | K250920 | Arthrex Spine Compression FT Screw | MRW | 2025-05-22 |
| 1476 | 1107746871 | K250728 | Arthrex Synergy Vision Endoscopic Imaging System | GCJ | 2025-05-05 |
| 1476 | 1919878028 | K250596 | Arthrex FiberTak Suture Anchor | MBI | 2025-03-28 |
| 1476 | 1088536452 | K250526 | Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor | MAI | 2025-03-14 |
| 1476 | 1875494070 | K250472 | SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS) | KTT | 2025-08-08 |
| 1476 | 1160847897 | K250424 | Arthrex TightRope Soft Button, RT | MBI | 2025-03-11 |
| 1476 | 1113423798 | K243995 | Arthrex Humeral Plating System and Cerclage Button | HRS | 2025-03-26 |
| 1476 | 1756433748 | K243890 | Arthrex Intramedullary Nails | HSB | 2025-01-13 |
| 1476 | 1423017407 | K243742 | Arthrex DynaNite Nitinol Staples | JDR | 2025-01-31 |
| 1476 | 1662034444 | K243602 | Arthrex Spine Endoscope | HRX | 2025-05-16 |
| 1476 | 1734211923 | K243480 | SuturePatch Tissue Reinforcement | OWX | 2025-05-29 |
| 1476 | 1282772245 | K243344 | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures | JDQ | 2025-02-20 |
| 1476 | 1828965006 | K243195 | Arthrex SS VAL and VAL KreuLock Compression Screw System | HWC | 2025-01-10 |
| 1476 | 1859891543 | K243008 | Arthrex NanoScope System | GCJ | 2025-01-22 |
| 1476 | 1662370570 | K242554 | Arthrex VAL and VAL KreuLock Compression Screw System | HRS | 2024-10-21 |
| 1476 | 1467689617 | K242079 | Arthrex Elbow Fracture Plating System | HRS | 2024-11-14 |
| 1476 | 1752443420 | K241592 | Arthrex VAL and VAL KreuLock Compression Screw System | HWC | 2024-08-31 |
| 1476 | 1534704471 | K241361 | Arthrex Synergy Vision Endoscopic Imaging System | GCJ | 2024-07-25 |
| 1476 | 1673854296 | K241235 | Arthrex TightRope II | MBI | 2024-05-29 |
| 1476 | 2027087365 | K241097 | Arthrex Virtual Implant Positioning (VIP) System Software | QHE | 2024-10-02 |
| 1476 | 1308155324 | K240815 | Arthrex Cannulated Screw System | HWC | 2024-06-13 |
| 1476 | 1659992168 | K233971 | Arthrex AlloSync PushLock Suture Anchor | MAI | 2024-06-04 |
| 1476 | 1655412181 | K233451 | Arthrex Synergy Vision Endoscopic Imaging System | GCJ | 2024-01-18 |
| 1476 | 1415126128 | K233260 | Univers Revers CA Head and Adapter | HSD | 2024-02-12 |
| 1476 | 1121776559 | K232973 | Arthrex Knee FiberTak® Button Suture Anchor | MBI | 2023-11-15 |
| 1476 | 1757039667 | K232897 | Arthrex Small External Fixation System | KTT | 2023-10-18 |
| 1476 | 1477854555 | K232755 | Arthrex FiberTape and TigerTape Cerclage Sutures | HTN | 2023-10-06 |
| 1476 | 2055837088 | K232742 | Arthrex FiberTak Suture Anchor | MBI | 2023-11-03 |
| 1476 | 1778673636 | K232340 | Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor | MBI | 2023-09-01 |
| 1476 | 1997653298 | K231857 | Arthrex TightRope II | MBI | 2023-08-08 |
| 1476 | 1546046700 | K231330 | FiberTak® Suture Anchor | MBI | 2023-06-01 |
| 1476 | 1570822525 | K231113 | Arthrex FiberTak Suture Anchor | MBI | 2023-05-18 |
| 1476 | 1242851426 | K230976 | Arthrex Radiopaque FiberTape Cerclage sutures | JDQ | 2023-08-24 |
| 1476 | 1790700568 | K230904 | Arthrex Virtual Implant Positioning (VIP) System | QHE | 2023-06-22 |
| 1476 | 1695834345 | K230568 | FiberTak Suture Anchor | MBI | 2023-04-01 |
| 1476 | 1870418486 | K230513 | Arthrex Univers Apex OptiFit Humeral Stem | KWS | 2023-09-26 |
| 1476 | 1044870499 | K230435 | Arthrex 3.9 mm SwiveLock Anchor | MAI | 2023-03-17 |
| 1476 | 1440889354 | K230433 | Arthrex Knotless FiberTak Suture Anchor | MBI | 2023-03-10 |
| 1476 | 1578407023 | K230366 | Arthrex Univers Revers Monoblock Stem Size 4/33 | PHX | 2023-04-10 |
| 1476 | 1531648479 | K230257 | Arthrex Intramedullary Nails | HSB | 2023-07-17 |
| 1476 | 1443177867 | K223759 | Arthrex SynergyID Endoscopic Imaging System | GCJ | 2023-02-24 |
| 1476 | 1768161671 | K223284 | SutureLoc Implant | MBI | 2023-02-02 |
| 1476 | 1573876330 | K222267 | Arthrex 2.4 mm Volar Distal Radius Plate System | HRS | 2022-10-03 |
| 1476 | 1650670333 | K222263 | Arthrex Self Punching SwiveLock Suture Anchors | MAI | 2022-08-26 |
| 1476 | 1847479353 | K222244 | Arthrex 3.5 mm Locking Compression Plates | HRS | 2022-09-30 |
| 1476 | 1765245744 | K222161 | Arthrex Knotless FiberTak Biceps Suture Anchor | MBI | 2022-08-11 |
| 1476 | 1700524171 | K222078 | Arthrex SoftStitch | GAT | 2022-09-14 |
| 1476 | 1310990545 | K222007 | Arthrex Virtual Implant Positioning (VIP) System | QHE | 2023-03-08 |
| 1476 | 1708862739 | K221485 | Arthrex FiberTape and TigerTape Cerclage Sutures | HTN | 2022-08-22 |
| 1476 | 1356488615 | K221396 | Arthrex FiberTak Suture Anchor | MBI | 2022-12-22 |
| 1476 | 1924876573 | K221354 | Arthrex SutureTape | GAT | 2022-09-09 |
| 1476 | 1388585094 | K221232 | Univers Revers Humeral Cup Implant | HSD | 2022-05-19 |
| 1476 | 1762055344 | K221128 | Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II | MAI | 2022-10-05 |
| 1476 | 1684588912 | K221099 | Arthrex Self-Punching PushLock Suture Anchor | MAI | 2022-05-13 |
| 1476 | 1224681026 | K221031 | Arthrex DualCompression Hindfoot Fusion Nail Implant System | HSB | 2022-12-20 |
| 1476 | 1719519637 | K220947 | Arthrex Knotless AC Repair Devices | HTN | 2022-06-06 |
| 1476 | 1637842578 | K220937 | Arthrex Mini Fragment System | HRS | 2022-06-29 |
| 1476 | 1846669727 | K220880 | Arthrex BioSuture | GAT | 2022-10-27 |
| 1476 | 1677258678 | K220839 | Arthrex Compression FT Pins | HWC | 2022-09-19 |
| 1476 | 2030593424 | K213837 | Arthrx Fracture Plates | HRS | 2022-05-02 |
| 1476 | 1586216255 | K213644 | Arthrex Knotless Mini TightRopes | HTN | 2021-12-17 |
| 1476 | 1766319841 | K213213 | Arthrex Vortex Threaded Bone Marrow Recovery Needle | KNW | 2021-11-19 |
| 1476 | 1991822174 | K212415 | Arthrex Modular Glenoid System-Titanium Glenosphere | PHX | 2021-11-17 |
| 1476 | 1710908924 | K212146 | Arthrex LoopLoc Knotless Suture | GAT | 2021-10-25 |
| 1476 | 1807206514 | K211074 | Univers Revers Modular Glenoid System, Standard Augment Baseplates | PHX | 2021-09-02 |
| 1476 | 2052033385 | K210994 | Arthrex Beveled FT Screws | HWC | 2021-06-01 |
| 1476 | 1264043169 | K210050 | Augmented VaultLock Glenoid | KWS | 2021-06-07 |
| 1476 | 1110199596 | K203834 | Arthrex Patella SuturePlates | HRS | 2021-03-25 |
Product Codes Associated With Registrations
| Product code | Registration listing records | Latest decision |
|---|---|---|
| HWC | 63 | 2026-05-08 |
| HRS | 60 | 2026-03-03 |
| MBI | 55 | 2026-03-20 |
| MAI | 46 | 2025-03-14 |
| HSB | 32 | 2026-03-20 |
| KWS | 24 | 2023-09-26 |
| GAT | 24 | 2022-10-27 |
| HTN | 18 | 2025-12-22 |
| GCJ | 15 | 2025-10-16 |
| HTY | 14 | 2020-06-29 |
| KTT | 11 | 2025-08-08 |
| PHX | 11 | 2023-04-10 |
| HRX | 10 | 2025-05-16 |
| JWH | 9 | 2015-11-12 |
| LLZ | 7 | 2020-04-30 |
| GEI | 7 | 2018-02-23 |
| HSX | 5 | 2025-07-01 |
| JDR | 5 | 2025-01-31 |
| HSD | 5 | 2024-02-12 |
| FRO | 5 | 2018-12-10 |
| FMF | 4 | 2015-07-07 |
| MQV | 4 | 2011-01-10 |
| JDQ | 3 | 2025-02-20 |
| QHE | 3 | 2024-10-02 |
| MBH | 3 | 2017-11-07 |
| KTW | 3 | 2017-06-22 |
| HIF | 3 | 2016-03-04 |
| KNW | 2 | 2021-11-19 |
| PKC | 2 | 2020-11-20 |
| DXJ | 2 | 2018-02-22 |
| KRR | 2 | 2016-04-12 |
| GAS | 2 | 2010-07-30 |
| LPH | 2 | 2010-04-22 |
| MNU | 2 | 2001-06-19 |
| OWY | 1 | 2025-09-30 |
| OWX | 1 | 2025-05-29 |
| MRW | 1 | 2025-05-22 |
| QHQ | 1 | 2019-07-26 |
| OSN | 1 | 2018-08-13 |
| PLF | 1 | 2015-08-12 |
PMA
PMN
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