HXA — Prosthesis, Tendon, Passive Class II
FDA Device Classification
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 |
| K872285 | holter-hausner intl | H-H HUNTER ACTIVE TENDON IMPLANT DC | September 28, 1987 |
| K872293 | holter-hausner intl | H-H HUNTER ACTIVE TENDON IMPLANT BC | 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 |