HWN — Instrument, Compression Class I
FDA product code HWN covers "Instrument, Compression", a Class I medical device regulated under 21 CFR 888.4540. Submissions are reviewed by the Orthopedic panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HWN
- 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 |
|---|---|---|---|
| K854241 | advanced ortho-technology | AOT EXTERNAL COMPRESS DEVICE | March 3, 1986 |
| K792253 | synthes (usa) | ARICULATED TENSION DEVICE SYNTHES TEN | December 5, 1979 |
| K770349 | richard wolf medical instruments | RIGID TEACHING ATTACHMENT | March 7, 1977 |
| K760970 | richard medical equip | FLORIO CPC BAND | November 23, 1976 |