Product code FSM
- Device name
- Tray, Surgical, Instrument
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K971217 | INSTRUMENT TRAY LINER | General Hospital Supply Corp. | 1997-05-06 |
| K962328 | SINGLE USE INSTRUMENT TRAY | Medcare Medical Group, Inc. | 1996-08-09 |
| K944025 | SURGICAL INSTRUMENT TRAY | Riley Medical, Inc. | 1994-11-22 |
| K912106 | ARTHROSCOPY TRAY | Medical Device Inspection Co., Inc. | 1991-08-29 |
| K912053 | OPEN HEART TRAY | Medical Device Inspection Co., Inc. | 1991-08-26 |
| K912052 | HEART CATH TRAY | Medical Device Inspection Co., Inc. | 1991-08-20 |
| K912104 | MAJOR BASIN TRAY | Medical Device Inspection Co., Inc. | 1991-08-09 |
| K910570 | SPLINTER TWEEZERS | Solan Scissors Sales | 1991-05-31 |
| K911601 | REDDICK TROCAR AND CANNULA | Ideal Medical, Inc. | 1991-05-21 |
| K910328 | KEY COMFORT GRIPS | Key Surgical, Inc. | 1991-03-06 |
| K905682 | RICHARD-ALLAN CLAMP COVERS | Richard-Allan Medical | 1991-02-19 |
| K900376 | HAND SURGERY AND IRRIGATION TRAY (MODEL 3625) | Pmt Corp. | 1990-04-10 |
| K894610 | CUSTOM TRAYS, KITS | L H M Ent., Inc. | 1990-03-15 |
| K900479 | STERILE LACERATION TRAY CAT. #749 | Busse Hospital Disposables, Inc. | 1990-02-13 |
| K895527 | THE NEEDLE COUNT AND SHARPS DISPOSAL SYSTEM | Quantitative Technologies, Inc. | 1989-10-06 |
| K883125 | CASF STERILIZATION TRAY | Terray Manufacturing, Inc. | 1988-08-10 |
| K883193 | CASF STERILIZATION TRAY | Terray Manufacturing, Inc. | 1988-08-10 |
| K882617 | BREVET CASSETTE STERILIZATION MODULE | Brevet, Inc. | 1988-07-28 |
| K871924 | STERILIZATION TRAY, TMJ INSTRUMENT SET | Arthropedics, Inc. | 1987-06-01 |
| K871478 | SURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYS | Procedure Pak, Inc. | 1987-05-07 |
| K870892 | MEDSURG PERCUTANEOUS ASPIRATION BIOPSY (PAB) TRAY | Medsurg Industries, Inc. | 1987-04-10 |
| K870417 | RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY | North Coast Medi-Tek | 1987-03-05 |
| K864920 | SCANLAN (TM) INSTRUMENT TRAY | Scanlan Intl., Inc. | 1987-01-12 |
| K863726 | INSTRUMENT STERILIZATION TRAY | Medical Technology Development Corp. | 1986-10-14 |
| K862629 | SURGICAL LASER ACCESSORIES (SLA) CASE | Simpson/Basye, Inc. | 1986-07-17 |
| K862154 | VENESECTION EQUIPMENT STORAGE TRAY | Rmp Co. | 1986-06-16 |
| K861530 | SURGICAL PACKS, KITS AND TRAYS | Medical Concepts Development, Inc. | 1986-05-30 |
| K861525 | DISPOSABLE SURG KITS/GOWNS/GUARDS/COVERS/MASKS | D & D Products, Inc. | 1986-05-06 |
| K860160 | OPERATING ROOM TRAY | Medical Design Concepts, Inc. | 1986-02-27 |
| K854746 | SURGICAL INSTRUMENT TRAY | Zbi, Inc. | 1985-12-17 |
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| 00840536823724 | VerteGlide Spinal Growth Guidance System | ORTHOPEDIATRICS CORP. | 2026-07-24 |
| 07640221370846 | SCALA | SpineArt SA | 2026-07-24 |
| 07640221370853 | SCALA | SpineArt SA | 2026-07-24 |
| 07640221370860 | SCALA | SpineArt SA | 2026-07-24 |
| 00190776422011 | Millennium | Avalign Technologies, Inc. | 2026-07-24 |
| 00190776421991 | Millennium | Avalign Technologies, Inc. | 2026-07-23 |
| 00190776422004 | Millennium | Avalign Technologies, Inc. | 2026-07-23 |
| 18059015378368 | Flexible Reamers System | ORTHOFIX SRL | 2026-07-23 |
| 18059015378375 | Flexible Reamers System | ORTHOFIX SRL | 2026-07-23 |
| 18059015378382 | Flexible Reamers System | ORTHOFIX SRL | 2026-07-23 |
| B803PW22A0 | ORTHOMED | ORTHO-MED, INC. | 2026-07-22 |
| B803PW12A0 | ORTHOMED | ORTHO-MED, INC. | 2026-07-22 |
| B803PW26A0 | ORTHOMED | ORTHO-MED, INC. | 2026-07-22 |
| B803PW30A0 | ORTHOMED | ORTHO-MED, INC. | 2026-07-22 |
| B803PW32A0 | ORTHOMED | ORTHO-MED, INC. | 2026-07-22 |
| B803PW40A0 | ORTHOMED | ORTHO-MED, INC. | 2026-07-22 |
| B803PW6G0 | ORTHOMED | ORTHO-MED, INC. | 2026-07-22 |
| B803PW20 | ORTHOMED | ORTHO-MED, INC. | 2026-07-22 |
| B803PW18A0 | ORTHOMED | ORTHO-MED, INC. | 2026-07-22 |
| B803PW14G0 | ORTHOMED | ORTHO-MED, INC. | 2026-07-22 |
| 00841731153265 | ARTEMIS TAKEDOWN | VILEX LLC | 2026-07-22 |
| 00841731153258 | ARTEMIS FUZE | VILEX LLC | 2026-07-22 |
| 00840606195737 | Viaduct | SPINAL ELEMENTS, INC. | 2026-07-20 |
| 00843059127478 | Lattus | TEDAN SURGICAL INNOVATIONS, L.L.C. | 2026-07-20 |
| 00810005668088 | Trigon | NVision Biomedical Technologies, Inc. | 2026-04-24 |
| 04546540364883 | NA | Stryker Leibinger GmbH & Co. KG | 2023-02-13 |
| 04546540210692 | NA | Stryker Leibinger GmbH & Co. KG | 2017-01-11 |
| 07613154170739 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-08 |
| 07613154130511 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-08 |