Product code LRP
- Device name
- Tray, Surgical
- 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 |
|---|---|---|---|
| K963723 | LACERATION TRAY | Grand Medical Products | 1996-11-27 |
| K951811 | OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK | Osteotech, Inc. | 1995-05-31 |
| K940239 | EYE TRAY | Cush Medical Products | 1994-06-28 |
| K935621 | CUSTOM ENT PACKS | Associated Medical | 1994-03-30 |
| K940646 | ORTHOPEDIC TRAY PRODUCT LINE | Cushindu | 1994-03-11 |
| K940444 | GENERAL SURGERY TRAY | Cush Medical Products | 1994-03-07 |
| K922126 | HOSPITAL KIT ENT 1125 | Savoy Medical Supply Co., Inc. | 1993-01-21 |
| K912105 | EYE TRAY | Medical Device Inspection Co., Inc. | 1991-08-29 |
| K903962 | INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE | Apk Technology | 1991-07-29 |
| K903963 | KITS AND TRAYS FOR ONE TIME USE ONLY | Apk Technology | 1991-07-29 |
| K905462 | PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES | Angiosystems, Inc. | 1991-02-06 |
| K903544 | CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS | J.J. Skinner, Inc. | 1990-08-31 |
| K890071 | STERILE LACERATION TRAY | Mumtaz I. Malik | 1989-01-24 |
| K883098 | SITE STERILIZATION TRAYS FOR OPHTHALMIC USE | Site Microsurgical Systems, Inc. | 1988-08-18 |
| K882275 | STERILE PACK (PROCEDURAL TRAY/KITS) | East Texas Lighthouse For the Blind | 1988-07-18 |
| K881095 | KOI(TM) INSTRUMENT TRAYS | CooperVision, Inc. | 1988-04-06 |
| K874665 | SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY | Precision Dynamics Corp. | 1988-01-20 |
| K873469 | TODD MEDICAL/SKILLED CARE PRODUCTS | Todd Medical, Inc. | 1987-10-29 |
| K873290 | LACERATION AND INSTRUMENT TRAYS | Advantage Medical Systems, Inc. | 1987-09-24 |
| K873439 | LACERATION TRAY | Ulti-Med Intl., Inc. | 1987-09-11 |
| K861142 | MASTER KIT B | Pro-Lab, Inc. | 1986-07-10 |
| K760497 | TRAY, SERVICE | Landmark Plastics | 1976-11-12 |
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|---|---|---|---|
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| 00840311265046 | Streamline® MIS Spinal Fixation System | Xtant Medical Holdings, Inc. | 2026-11-02 |
| 00840311265039 | Streamline® MIS Spinal Fixation System | Xtant Medical Holdings, Inc. | 2026-11-02 |
| 00840311265022 | Streamline® MIS Spinal Fixation System | Xtant Medical Holdings, Inc. | 2026-11-02 |
| 00840311265015 | Streamline® MIS Spinal Fixation System | Xtant Medical Holdings, Inc. | 2026-11-02 |
| 00840311264995 | Streamline® MIS Spinal Fixation System | Xtant Medical Holdings, Inc. | 2026-11-02 |
| 00840311264988 | Streamline® MIS Spinal Fixation System | Xtant Medical Holdings, Inc. | 2026-11-02 |
| 00840311264971 | Streamline® MIS Spinal Fixation System | Xtant Medical Holdings, Inc. | 2026-11-02 |
| 00840311264964 | Streamline® MIS Spinal Fixation System | Xtant Medical Holdings, Inc. | 2026-11-02 |
| 00840311264957 | Streamline® MIS Spinal Fixation System | Xtant Medical Holdings, Inc. | 2026-11-02 |
| 00840311264933 | Streamline® MIS Spinal Fixation System | Xtant Medical Holdings, Inc. | 2026-11-02 |
| 00840311264926 | Streamline® MIS Spinal Fixation System | Xtant Medical Holdings, Inc. | 2026-11-02 |
| 00840311264919 | Streamline® MIS Spinal Fixation System | Xtant Medical Holdings, Inc. | 2026-11-02 |
| 00840311264902 | Streamline® MIS Spinal Fixation System | Xtant Medical Holdings, Inc. | 2026-11-02 |
| 00840311264896 | Streamline® MIS Spinal Fixation System | Xtant Medical Holdings, Inc. | 2026-11-02 |
| 00840311264889 | Streamline® MIS Spinal Fixation System | Xtant Medical Holdings, Inc. | 2026-11-02 |
| 00840311264872 | Streamline® MIS Spinal Fixation System | Xtant Medical Holdings, Inc. | 2026-11-02 |
| 00840311264858 | Streamline® MIS Spinal Fixation System | Xtant Medical Holdings, Inc. | 2026-11-02 |
| 00840311264940 | Streamline® MIS Spinal Fixation System | Xtant Medical Holdings, Inc. | 2026-11-02 |
| 00810017915194 | ALIF, Disc Prep Bottom Level | ELEVATION SPINE, INC. | 2026-10-30 |
| 10198956623262 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2026-10-29 |
| 10198956623255 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2026-10-29 |
| 10198956620421 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2026-10-29 |
| 10198956609037 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2026-10-29 |
| 10198956608078 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2026-10-29 |
| 10198956601550 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2026-10-29 |
| 10198956593879 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2026-10-29 |
| 10198956589612 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2026-10-29 |
| 10198956566576 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2026-10-29 |
| 00642356007298 | Mastel Surgical | Mastel Surgical Inc. | 2026-10-29 |