HWT — Template Class I
FDA product code HWT covers "Template", a Class I medical device regulated under 21 CFR 888.4800. Submissions are reviewed by the Orthopedic panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HWT
- Device Class
- Class I
- Regulation Number
- 888.4800
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K974406 | ortho-graphics | ORTHOPLAN | February 18, 1998 |
| K960685 | integrated surgical systems | ORTHODOC PREOPERATIVE PLANNER MODEL 500 | January 17, 1997 |
| K894228 | kronner medical | KRONNER SPHERICAL CUTTERS | July 23, 1990 |
| K870843 | warsaw orthopedic | SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA | May 27, 1987 |
| K871323 | orthopedic systems | ARTHROSCOPIC MENISCAL SUTURE SYSTEM | May 1, 1987 |
| K830360 | 3m | 3M OSTEOTOMY GUIDE | March 1, 1983 |
| K811205 | shannon group | MOLDED POLYSULFONE TRIAL PROSTHESIS | May 21, 1981 |
| K781091 | biomet | KNEE INSTRUMENTATION, CONDYLAR | July 17, 1978 |
| K771710 | depuy | WORRELL PATELLA TEMPLATE | October 6, 1977 |
| K771709 | depuy | WORRELL TRIAL PATELLA | October 6, 1977 |