HTP — File Class I
FDA product code HTP covers "File", a Class I medical device regulated under 21 CFR 888.4540. Submissions are reviewed by the Orthopedic panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HTP
- 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 |
|---|---|---|---|
| K931733 | Intermedics Orthopedics | INTERMEDICS ORTHOPEDICS REAMERS | Jan 26, 1994 |
| K870842 | Warsaw Orthopedic | SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP | May 27, 1987 |
| K862659 | Concept | CONCEPT ARTHROSCOPY RASP | Sep 2, 1986 |
| K841981 | Stainless Mfg | 4MM & 5MM FILE | Jun 19, 1984 |
| K840492 | Suncoast Medical Manufacturers | SUN-LITE BLUE SLIT | May 9, 1984 |