Data / Medical devices / United States / Arthrex, Inc.
Arthrex, Inc.: FDA-registered device maker in Naples, FL, United States, 378 510(k) clearances
Arthrex, Inc. is registered with the FDA (registration 1220246) in Naples, FL, United States. It lists 121 device types. The FDA files 378 510(k) clearances under its listings, the newest dated September 25, 2026. 18 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1220246
- Address
- 1370 Creekside Blvd, Naples, FL, United States, 34108
- Owner or operator
- ARTHREX, INC. (1220287)
- Roles
- Manufacturer, Specification developer
- First device listed
- January 27, 1994
- Registered through
- 2027
- Brand names listed
- 40 L HIGH FLOW INSUFFLATOR F108, ACCIN Bipolar Head System, ACCIN Patellofemoral System, ACCIN Total Knee System, ACCIN Uni-Knee System, ACL TightRope, ACL TightRope Double Bundle, AESCULAP STERILCONTAINER SYSTEM 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 378.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 25, 2026 | K262975 | Arthrex Beaming System | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 24, 2026 | K262618 | Arthrex Spine Compression FT Screw | MRW | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 1, 2026 | K262451 | Arthrex DynaNite Staples | JDR | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 7, 2026 | K262357 | Arthrex Bioabsorbable PushLock Suture Anchors | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 30, 2026 | K260624 | Arthrex Radial Head Replacement System | KWI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 26, 2026 | K260018 | Arthrex FiberButton | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 25, 2026 | K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw System | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 28, 2026 | K253931 | Arthrex Bioabsorbable PushLock Suture Anchors | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 8, 2026 | K254215 | Arthrex Beaming System | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 20, 2026 | K260561 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 20, 2026 | K252016 | Arthrex Humeral Nails | HSB | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 9, 2026 | K260405 | FiberTape Button | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 5, 2026 | K252196 | Arthrex FibuLock Nail System | HSB | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 3, 2026 | K260353 | Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 2, 2026 | K254229 | Arthrex Nano FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 21, 2026 | K253713 | Arthrex Variable Angle (VA) Proximal Tibia Plating System | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 12, 2026 | K252807 | Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 30, 2025 | K253895 | Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 22, 2025 | K253727 | Syndesmosis TightRope PRO | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 29, 2025 | K252314 | Arthrex SutureTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 16, 2025 | K251994 | Arthrex Synergy Vision Imaging System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 30, 2025 | K251690 | Arthrex SpeedFLEX Implant | OWY | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 8, 2025 | K250472 | SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS) | KTT | Substantially Equivalent | Amdt Holdings, Inc. | accessdata.fda.gov |
| July 18, 2025 | K251809 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 10, 2025 | K251145 | Arthrex PushLock Suture Anchors | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 1, 2025 | K251453 | Arthrex iBalance Partial Knee System | HSX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 29, 2025 | K243480 | SuturePatch Tissue Reinforcement | OWX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 22, 2025 | K250920 | Arthrex Spine Compression FT Screw | MRW | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 16, 2025 | K243602 | Arthrex Spine Endoscope | HRX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 5, 2025 | K250728 | Arthrex Synergy Vision Endoscopic Imaging System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 28, 2025 | K250596 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 26, 2025 | K243995 | Arthrex Humeral Plating System and Cerclage Button | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 14, 2025 | K250526 | Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 11, 2025 | K250424 | Arthrex TightRope Soft Button, RT | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 20, 2025 | K243344 | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures | JDQ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 31, 2025 | K243742 | Arthrex DynaNite Nitinol Staples | JDR | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 22, 2025 | K243008 | Arthrex NanoScope System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 13, 2025 | K243890 | Arthrex Intramedullary Nails | HSB | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 10, 2025 | K243195 | Arthrex SS VAL and VAL KreuLock Compression Screw System | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 14, 2024 | K242079 | Arthrex Elbow Fracture Plating System | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 21, 2024 | K242554 | Arthrex VAL and VAL KreuLock Compression Screw System | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 2, 2024 | K241097 | Arthrex Virtual Implant Positioning (VIP) System Software | QHE | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 31, 2024 | K241592 | Arthrex VAL and VAL KreuLock Compression Screw System | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 25, 2024 | K241361 | Arthrex Synergy Vision Endoscopic Imaging System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 13, 2024 | K240815 | Arthrex Cannulated Screw System | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 4, 2024 | K233971 | Arthrex AlloSync PushLock Suture Anchor | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 29, 2024 | K241235 | Arthrex TightRope II | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 12, 2024 | K233260 | Univers Revers CA Head and Adapter | HSD | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 18, 2024 | K233451 | Arthrex Synergy Vision Endoscopic Imaging System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 15, 2023 | K232973 | Arthrex Knee FiberTak® Button Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 3, 2023 | K232742 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 18, 2023 | K232897 | Arthrex Small External Fixation System | KTT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 6, 2023 | K232755 | Arthrex FiberTape and TigerTape Cerclage Sutures | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 26, 2023 | K230513 | Arthrex Univers Apex OptiFit Humeral Stem | KWS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 1, 2023 | K232340 | Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 24, 2023 | K230976 | Arthrex Radiopaque FiberTape Cerclage sutures | JDQ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 8, 2023 | K231857 | Arthrex TightRope II | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 17, 2023 | K230257 | Arthrex Intramedullary Nails | HSB | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 22, 2023 | K230904 | Arthrex Virtual Implant Positioning (VIP) System | QHE | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 1, 2023 | K231330 | FiberTak® Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 18, 2023 | K231113 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 10, 2023 | K230366 | Arthrex Univers Revers Monoblock Stem Size 4/33 | PHX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 1, 2023 | K230568 | FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 17, 2023 | K230435 | Arthrex 3.9 mm SwiveLock Anchor | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 10, 2023 | K230433 | Arthrex Knotless FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 8, 2023 | K222007 | Arthrex Virtual Implant Positioning (VIP) System | QHE | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 24, 2023 | K223759 | Arthrex SynergyID Endoscopic Imaging System | GCJ | Substantially Equivalent | Arthex, Inc. | accessdata.fda.gov |
| February 2, 2023 | K223284 | SutureLoc Implant | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 22, 2022 | K221396 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 20, 2022 | K221031 | Arthrex DualCompression Hindfoot Fusion Nail Implant System | HSB | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 27, 2022 | K220880 | Arthrex BioSuture | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 5, 2022 | K221128 | Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 3, 2022 | K222267 | Arthrex 2.4 mm Volar Distal Radius Plate System | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 30, 2022 | K222244 | Arthrex 3.5 mm Locking Compression Plates | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 19, 2022 | K220839 | Arthrex Compression FT Pins | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 14, 2022 | K222078 | Arthrex SoftStitch | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 9, 2022 | K221354 | Arthrex SutureTape | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 26, 2022 | K222263 | Arthrex Self Punching SwiveLock Suture Anchors | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 22, 2022 | K221485 | Arthrex FiberTape and TigerTape Cerclage Sutures | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 11, 2022 | K222161 | Arthrex Knotless FiberTak Biceps Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 29, 2022 | K220937 | Arthrex Mini Fragment System | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 6, 2022 | K220947 | Arthrex Knotless AC Repair Devices | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 19, 2022 | K221232 | Univers Revers Humeral Cup Implant | HSD | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 13, 2022 | K221099 | Arthrex Self-Punching PushLock Suture Anchor | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 2, 2022 | K213837 | Arthrx Fracture Plates | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 17, 2021 | K213644 | Arthrex Knotless Mini TightRopes | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 19, 2021 | K213213 | Arthrex Vortex Threaded Bone Marrow Recovery Needle | KNW | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 17, 2021 | K212415 | Arthrex Modular Glenoid System-Titanium Glenosphere | PHX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 25, 2021 | K212146 | Arthrex LoopLoc Knotless Suture | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 2, 2021 | K211074 | Univers Revers Modular Glenoid System, Standard Augment Baseplates | PHX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 22, 2021 | K202582 | Arthrex SynergyID Endoscopic Imaging System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 7, 2021 | K210050 | Augmented VaultLock Glenoid | KWS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 1, 2021 | K210994 | Arthrex Beveled FT Screws | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 19, 2021 | K203495 | Arthrex SwiveLock Anchor | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 25, 2021 | K203834 | Arthrex Patella SuturePlates | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 3, 2021 | K203294 | Arthrex Pilon Fusion System | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 30, 2020 | K203239 | Arthrex Low Profile Screws | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 16, 2020 | K203180 | Arthrex DynaNite Nitinol Staples | JDR | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 27, 2020 | K203268 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 20, 2020 | K203100 | Arthrex Eclipse Titanium Humeral Head | PKC | Substantially Equivalent | Arthrex, 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 |
|---|---|---|---|---|---|---|
| November 2, 2022 | 91143 | Class II | Ongoing | Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulated reamer, sterile. | The devices may be packaged with the wrong reamer size. | accessdata.fda.gov |
| March 25, 2022 | 89984 | Class II | Terminated | K-Wire, 1.35 mm x 170 mm | Products do not meet length and diameter specifications. | accessdata.fda.gov |
| June 14, 2021 | 88200 | Class II | Ongoing | Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC | Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch. | accessdata.fda.gov |
| March 11, 2021 | 87584 | Class II | Terminated | Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur. | It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts. | accessdata.fda.gov |
| February 24, 2021 | 87481 | Class II | Terminated | Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures. | The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color. | accessdata.fda.gov |
| June 24, 2020 | 86021 | Class II | Terminated | Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a plate-screw system for internal bone fixation for bone fractures, fu | Screws provided in packaging are 5mm shorter than intended | accessdata.fda.gov |
| December 17, 2019 | 84594 | Class II | Terminated | Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide | There is a potential for blockage of the Hub Attachment Tube. | accessdata.fda.gov |
| October 1, 2019 | 84030 | Class II | Terminated | Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intended to provide internal unicortical or bicortical bone fixation. | Screws provided in the device package are 6 mm longer than intended. | accessdata.fda.gov |
| January 14, 2019 | 82009 | Class II | Terminated | Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft and osseous tissues in both large and small articular cavities during arthroscopic procedures. | Devices may generate excessive heat during use. | accessdata.fda.gov |
| November 19, 2018 | 81819 | Class II | Ongoing | Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Number AR-1317FT Product Usage: Soft tissue fixation to bone in the hand and wrist | Potentially lead to anchor breakage during insertion | accessdata.fda.gov |
| September 13, 2018 | 81119 | Class II | Ongoing | 3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumentation for the implantation of the FibuLock implant. Contents include: Act | There is potential to break during use. | accessdata.fda.gov |
| August 27, 2018 | 81106 | Class II | Ongoing | Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing is used to house the battery that powers the AR-400 DrillSaw Sports 400 device. | The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not provide a complete seal around the battery, allowing for potential fluid ingress. | accessdata.fda.gov |
| October 3, 2017 | 78297 | Class II | Terminated | iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthrex, Inc., Naples, FL Indicated for use in uni-compartmental knee arthroplasty as a result of: 1. Mode | Arthrex part number AR-501-UFLC, size 3, batch 10123297, has the incorrect part number AR-501 UFRA, size 1 printed on the patient label inside the box. | accessdata.fda.gov |
| March 24, 2017 | 76986 | Class II | Terminated | Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching | Some eyelets broke from SwiveLock Anchor on insertion. | accessdata.fda.gov |
| August 12, 2016 | 75050 | Class III | Terminated | Arthrex Suture Washer | The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package. | accessdata.fda.gov |
| April 22, 2016 | 74084 | Class II | Terminated | BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot. | Potential for polystyrene particulate presence. | accessdata.fda.gov |
| January 11, 2016 | 73579 | Class II | Terminated | Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons. | Potential for a component contained in the Implant System to be non-sterile. | accessdata.fda.gov |
| December 17, 2015 | 73204 | Class II | Terminated | Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG, Size 7 -Catalog # AR-503-TTT | Devices reported to have a smooth texture to the outer surface of the metal, which differed from a previous that had a textured outer surface. | accessdata.fda.gov |
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Updated September 25, 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.