Panels › General, Plastic Surgery › Product code FSM · Class 1
Tray, Surgical, Instrument
Regulation 878.4800
0510(k)s in 12 months (76 all time)
4recalls in 12 months (40 all time)
3recalls that name a 510(k)
Top companies in FSM
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2026 | Howmedica Osteonics Corp. TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519. Open, Classified |
FSM | None listed |
| Oct 15, 2026 | Howmedica Osteonics Corp. Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514. Open, Classified |
FSM | None listed |
| Oct 15, 2026 | Howmedica Osteonics Corp. TS Femoral Prep Tray, Triathlon. Catalog Number: 6543-6-507. Open, Classified |
FSM | None listed |
| Oct 15, 2026 | Howmedica Osteonics Corp. TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506. Open, Classified |
FSM | None listed |
| Sep 10, 2025 | Encore Medical, LP Brand Name: DJO SURGICAL
Product Name: FA S Altivate Reverse Glenoid Tray
Model/Catalog Number: None
Software Version: NA
Product Description: Enovis" shoulder devices are intended for treatment of pa Open, Classified |
FSM | K233481 |
| Sep 12, 2024 | Medical Action Industries, Inc. 306 Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each /case), 6060 (8 rolls/case), 6070 (75 each/case), 6106 (250 each/case), 6141 (250 each/case), 6203 (40 each/case), 6805 (50 Open, Classified |
FSM | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
1) PSP - VAMC LONG BEACH, Pack Number 146255;
2) INSERTION TRAY, Pack Number CVI5080;
3) INCISION & DRAINAGE TRAY, Pack Number DYNDA1063;
4) DRAINAGE ACCESS P Open, Classified |
FSM | None listed |
| Feb 25, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Kits, trays, and packs labeled as follows:
TRAY,L&D INSTRUMENT, REF DYNDL1550 Open, Classified |
FSM | None listed |
| Apr 25, 2023 | Aesculap Implant Systems LLC Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Lid Only. A lid to a container intended to provide a suitable platform for plac Open, Classified |
FSM | None listed |
| Jan 11, 2023 | Stradis Healthcare Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare. Open, Classified |
FSM | None listed |
| Jan 11, 2023 | Stradis Healthcare Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein. Open, Classified |
FSM | None listed |
| Nov 24, 2021 | Howmedica Osteonics Corp. Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usable instruments required for implanting the Triathlon Globalizati Open, Classified |
FSM | None listed |
| Jun 10, 2019 | Zimmer Biomet, Inc. Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510 Terminated |
FSM | None listed |
| Jun 10, 2019 | Zimmer Biomet, Inc. Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509 Terminated |
FSM | None listed |
| Nov 28, 2018 | Zimmer Biomet, Inc. Maximum Variable Pitch Compression Screw Caddy, Reference Number 231201003
Product Usage:
Intended to carry implants and instruments during regular inventory distribution and handling and sterilizati Terminated |
FSM | None listed |
| Nov 28, 2018 | Zimmer Biomet, Inc. Maximum Variable Pitch Compression Tray Base, Reference Number 231201002
Product Usage:
Intended to carry implants and instruments during regular inventory distribution and handling and sterilization Terminated |
FSM | None listed |
| Mar 5, 2018 | Synthes (USA) Products LLC Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set Terminated |
FSM | None listed |
| Mar 5, 2018 | Synthes (USA) Products LLC Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set Terminated |
FSM | None listed |
| Mar 5, 2018 | Synthes (USA) Products LLC Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set Terminated |
FSM | None listed |
| Dec 21, 2016 | Synthes (USA) Products LLC Synthes VA Implant Rack for the Compact Distal Radius System
Tray/Surgical/Instrument Terminated |
FSM | None listed |
| Nov 15, 2016 | Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse Hospital Disposables Hauppauge, NY --- Device Listing # A343147 Terminated |
FSM | None listed |
| Oct 8, 2015 | Stryker Craniomaxillofacial Division Disposable Paper Filter for Sterilization Containers
Paper, Medical Accessory, 100 DISP, Paper F, Steri.Cases, New Shape, Manufactured and distributed by Stryker Leibinger GmbH & Co KG, Distributed i Terminated |
FSM | None listed |
| Oct 6, 2015 | Zimmer, Inc. Zimmer Universal Locking System, Titanium 3.5mm.
Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, Terminated |
FSM | None listed |
| Aug 20, 2015 | Synthes (USA) Products LLC Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails; the Nail Wrap is intended to be used as a protective sheath specifically for Universal Femoral Nails, Unive Terminated |
FSM | None listed |
| Aug 20, 2014 | Zimmer, Inc. PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile
The intended use of the sterilization case is to organize, store and protect its contents from damage consistent Terminated |
FSM | None listed |
| Aug 20, 2014 | Zimmer, Inc. PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile
The intended use of the sterilization case is to organize, store and protect its contents from damage consistent Terminated |
FSM | None listed |
| Aug 13, 2013 | SpineFrontier, Inc. Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid: 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A, 11-60046A, 11-60053A; Invue Lid: SI70095A; S-Lift L Terminated |
FSM | None listed |
| Aug 8, 2013 | SpineFrontier, Inc. Indus Invue Screw Caddy, Model: SI70097
The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates and screws used during fixation of anterior cervical plates t Terminated |
FSM | K121060 |
| Aug 1, 2013 | SpineFrontier, Inc. Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B
The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw Terminated |
FSM | None listed |
| Jul 5, 2013 | SpineFrontier, Inc. BASE, S-LIFT Instrument Case
Product Usage:
System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants Terminated |
FSM | K092815 |
| Mar 28, 2013 | Cardinal Health Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capacity; Sterile; Removable Numbered Foam Block; Double Numbered Magnets (Cat. No. 4FM100SSA)
Product Usage:
Disposal system f Terminated |
FSM | None listed |
| Mar 28, 2013 | Cardinal Health Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA70SSA)
Needle Counters with Blade Disarmer; 12.2 x Terminated |
FSM | None listed |
| Mar 28, 2013 | Cardinal Health Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/80 Capacity; Sterile; Double Removable Numbered Foam Blocks (Cat. No. 3FF80SSA)
Product Usage:
Disposal system for counting of used surgical blades and Terminated |
FSM | None listed |
| Mar 28, 2013 | Cardinal Health Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA70SSA)
Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Ste Terminated |
FSM | None listed |
| Mar 28, 2013 | Cardinal Health Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 4FS60SSA)
Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 C Terminated |
FSM | None listed |
| Mar 28, 2013 | Cardinal Health Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 3FS60SSA)
Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Terminated |
FSM | None listed |
| Mar 28, 2013 | Cardinal Health Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FS30SSA)
Needle Counters with Blade Disarmer; 11.5 x 6 Terminated |
FSM | None listed |
| Mar 28, 2013 | Cardinal Health Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA40SSA)
Needle Counters with Blade Disarmer; 11.5 x 6 Terminated |
FSM | None listed |
| Mar 28, 2013 | Cardinal Health Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA40SSA)
Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Steri Terminated |
FSM | None listed |
| Mar 21, 2012 | Customed, Inc Incision and Drainage Tray, catalog# 900-774 Terminated |
FSM | None listed |
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