ITS — Joint, Hip, External Brace Class I
FDA product code ITS covers "Joint, Hip, External Brace", a Class I medical device regulated under 21 CFR 890.3475. Submissions are reviewed by the Physical Medicine panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- ITS
- Device Class
- Class I
- Regulation Number
- 890.3475
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K780891 | hosmer dorrance | POST-OPERATIVE HIP ORTHOSIS | June 13, 1978 |