HTS — Knife, Orthopedic Class I
FDA product code HTS covers "Knife, Orthopedic", a Class I medical device regulated under 21 CFR 888.4540. Submissions are reviewed by the Orthopedic panel. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HTS
- Device Class
- Class I
- Regulation Number
- 888.4540
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K930507 | associated medical products | CUSTOM ORTHOPAEDIC TRAYS (PACKS) | February 22, 1994 |
| K933921 | acufex microsurgical | ACUFLEX DISPOSABLE KNIVES | January 26, 1994 |
| K882525 | karlin technology | SPINAL MICROKNIFE | September 22, 1988 |
| K873714 | arthropedics | BANANA KNIFE, DISPOSABLE #TM-1612 | November 2, 1987 |
| K873713 | arthropedics | TRIANGULAR KNIFE, DISPOSABLE #TM-1611 | November 2, 1987 |
| K873711 | arthropedics | RETROGRADE KNIFE, DISPOSABLE #TM-1613 | November 2, 1987 |
| K873712 | arthropedics | STANDARD KNIFE, DISPOSABLE #TM-1610 | October 15, 1987 |
| K842820 | medtech industries | ARTHROSCOPY KNIVES | August 14, 1984 |
| K771851 | richard wolf medical instruments | ARTHROSCOPE OPERATIVE KNIFE SET | October 27, 1977 |