File
FDA product code HTP · Class I (low risk) · 21 CFR 888.4540 · Orthopedic
5510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K931733 | Intermedics Orthopedics ReamersHTP · Traditional | Intermedics Orthopedics | 01/26/1994SE |
| K870842 | Schultz Phalangeal Comp Rasp/Metacarpal Comp RaspHTP · Traditional | Warsaw Orthopedic, Inc. | 05/27/1987SE |
| K862659 | Concept Arthroscopy RaspHTP · Traditional | Concept, Inc. | 09/02/1986SE |
| K841981 | 4MM & 5MM FileHTP · Traditional | Stainless Mfg., Inc. | 06/19/1984SE |
| K840492 | Sun-Lite Blue SlitHTP · Traditional | Suncoast Medical Manufacturers, Inc. | 05/09/1984SE |