HXA — Prosthesis, Tendon, Passive Class II
FDA product code HXA covers "Prosthesis, Tendon, Passive", a Class II medical device regulated under 21 CFR 888.3025. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HXA
- Device Class
- Class II
- Regulation Number
- 888.3025
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243477 | askorn medical | Universal Tendon Spacer | January 10, 2025 |
| K000019 | medist international | SINGLE SIZE TENDON SPACER | March 29, 2000 |
| K973385 | technical products | OVAL SHAPES | December 5, 1997 |
| K964359 | avanta orthopaedics | AVANTA ORTHOPAEDICS TENDON SPACER | March 25, 1997 |
| K930125 | phoenix bioengineering | PHOENIX BONE SCREWS PBS-TYPE SERIES | December 30, 1993 |
| K872284 | holter-hausner intl | H-H HUNTER ACTIVE TENDON IMPLANT PC | September 28, 1987 |
| K872293 | holter-hausner intl | H-H HUNTER ACTIVE TENDON IMPLANT BC | September 28, 1987 |
| K872285 | holter-hausner intl | H-H HUNTER ACTIVE TENDON IMPLANT DC | September 28, 1987 |
| K853438 | holter-hausner intl | H-H HUNTER ACTIVE TENDON IMPLANT | September 30, 1985 |
| K781943 | holter-hausner intl | TENDON ROD MODEL OR41PO3-6 | December 4, 1978 |
| K780320 | holter-hausner intl | PASSIVE TENDON IMPLANT | March 17, 1978 |