HSR — Unit, Traction, Hip, Non-Powered, Non-Penetrating Class I
FDA product code HSR covers "Unit, Traction, Hip, Non-Powered, Non-Penetrating", a Class I medical device regulated under 21 CFR 888.5890. Submissions are reviewed by the Orthopedic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- HSR
- Device Class
- Class I
- Regulation Number
- 888.5890
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K780763 | orthopedic equipment co | ENTRAX TRACTION UNIT | May 16, 1978 |