Product code HTS
- Device name
- Knife, Orthopedic
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.4540
- Review panel
- OR
- 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 |
|---|---|---|---|
| K930507 | CUSTOM ORTHOPAEDIC TRAYS (PACKS) | Associated Medical Products Co. | 1994-02-22 |
| K933921 | ACUFLEX DISPOSABLE KNIVES | Acufex Microsurgical, Inc. | 1994-01-26 |
| K882525 | SPINAL MICROKNIFE | Karlin Technology, Inc. | 1988-09-22 |
| K873711 | RETROGRADE KNIFE, DISPOSABLE #TM-1613 | Arthropedics, Inc. | 1987-11-02 |
| K873713 | TRIANGULAR KNIFE, DISPOSABLE #TM-1611 | Arthropedics, Inc. | 1987-11-02 |
| K873714 | BANANA KNIFE, DISPOSABLE #TM-1612 | Arthropedics, Inc. | 1987-11-02 |
| K873712 | STANDARD KNIFE, DISPOSABLE #TM-1610 | Arthropedics, Inc. | 1987-10-15 |
| K842820 | ARTHROSCOPY KNIVES | Medtech Industries, Inc. | 1984-08-14 |
| K771851 | ARTHROSCOPE OPERATIVE KNIFE SET | Richard Wolf Medical Instruments Corp. | 1977-10-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10705034576145 | N/A | DEPUY SPINE, LLC | 2024-02-22 |
| 14026704798992 | PILLING | TELEFLEX INCORPORATED | 2022-12-08 |
| 14026704798985 | PILLING | TELEFLEX INCORPORATED | 2022-12-08 |
| 14026704798978 | PILLING | TELEFLEX INCORPORATED | 2022-12-08 |
| 14026704798961 | PILLING | TELEFLEX INCORPORATED | 2022-12-08 |
| 00192896105614 | Arthroscopic Toothed Knife | SONTEC INSTRUMENTS, INC. | 2020-11-18 |
| 00192896105508 | Foerner Sesamoid Knife | SONTEC INSTRUMENTS, INC. | 2020-11-16 |
| 00192896105478 | Piermattei Smillie Meniscotome | SONTEC INSTRUMENTS, INC. | 2020-11-16 |
| 10845854024461 | CONMED | Conmed Corporation | 2020-09-24 |
| 00811801031786 | Battalion | ALPHATEC SPINE, INC. | 2020-09-19 |
| 00844856042612 | Illico | ALPHATEC SPINE, INC. | 2020-06-17 |
| 10381780408321 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-08-16 |
| 10381780408338 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-08-16 |
| 10381780479031 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-08-16 |
| 10381780479420 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-08-16 |
| 10381780185178 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780185185 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780185161 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780427414 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-10 |
| 10381780427407 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-10 |
| 10381780427391 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-10 |
| 10705034494203 | NA | DEPUY SPINE, LLC | 2017-06-20 |
| 10705034325330 | NA | DEPUY SPINE, LLC | 2017-01-26 |
| 10705034189932 | ALIF | DEPUY SPINE, LLC | 2016-12-31 |
| 10705034189925 | ALIF | DEPUY SPINE, LLC | 2016-12-31 |
| 10705034187006 | PLIF | DEPUY SPINE, LLC | 2016-12-31 |
| 10705034000916 | NA | DEPUY SPINE, LLC | 2016-12-31 |
| 10810190018344 | Straight Hip Blade, Sharp Tip | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2016-09-24 |
| 10810190018351 | Straight Hip Blade, Blunt Tip | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2016-09-24 |
| 10705034489605 | NA | DEPUY SPINE, LLC | 2016-08-23 |