FDA Product Code
FDA Product Code HXA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3025
510(k) Clearances — 11 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243477 | Universal Tendon Spacer | Askorn Medical | 2025-01-10 | Traditional | PDF ↗ |
| K000019 | SINGLE SIZE TENDON SPACER | Medist International | 2000-03-29 | Traditional | PDF ↗ |
| K973385 | OVAL SHAPES | Technical Products, Inc. | 1997-12-05 | Traditional | PDF ↗ |
| K964359 | AVANTA ORTHOPAEDICS TENDON SPACER | Avanta Orthopaedics, Inc. | 1997-03-25 | Traditional | PDF ↗ |
| K930125 | PHOENIX BONE SCREWS PBS-TYPE SERIES | Phoenix Bioengineering, Inc. | 1993-12-30 | Traditional | PDF ↗ |
| K872293 | H-H HUNTER ACTIVE TENDON IMPLANT BC | Holter-Hausner Intl. | 1987-09-28 | Traditional | PDF ↗ |
| K872284 | H-H HUNTER ACTIVE TENDON IMPLANT PC | Holter-Hausner Intl. | 1987-09-28 | Traditional | PDF ↗ |
| K872285 | H-H HUNTER ACTIVE TENDON IMPLANT DC | Holter-Hausner Intl. | 1987-09-28 | Traditional | PDF ↗ |
| K853438 | H-H HUNTER ACTIVE TENDON IMPLANT | Holter-Hausner Intl. | 1985-09-30 | Traditional | PDF ↗ |
| K781943 | TENDON ROD MODEL OR41PO3-6 | Holter-Hausner Intl. | 1978-12-04 | Traditional | PDF ↗ |
| K780320 | PASSIVE TENDON IMPLANT | Holter-Hausner Intl. | 1978-03-17 | Traditional | PDF ↗ |
Product code HXA · Class II · Orthopedic. Data: openFDA.