Panels › Orthopedic › Product code HXA · Class 2
Prosthesis, Tendon, Passive
Regulation 888.3025
0510(k)s in 12 months (11 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in HXA
| Company | 510(k)s | Recalls |
|---|---|---|
| Holter-Hausner Intl. | 6 | 0 |
| Askorn Medical | 1 | 0 |
| Avanta Orthopaedics, Inc. | 1 | 0 |
| Medist International | 1 | 0 |
| Phoenix Bioengineering, Inc. | 1 | 0 |
| Technical Products, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 10, 2025 | K243477 | Universal Tendon Spacer Askorn Medical, FR | HXA |
| Mar 29, 2000 | K000019 | SINGLE SIZE TENDON SPACER Medist International | HXA |
| Dec 5, 1997 | K973385 | OVAL SHAPES Technical Products, Inc. | HXA |
| Mar 25, 1997 | K964359 | AVANTA ORTHOPAEDICS TENDON SPACER Avanta Orthopaedics, Inc. | HXA |
| Dec 30, 1993 | K930125 | PHOENIX BONE SCREWS PBS-TYPE SERIES Phoenix Bioengineering, Inc. | HXA |
| Sep 28, 1987 | K872293 | H-H HUNTER ACTIVE TENDON IMPLANT BC Holter-Hausner Intl. | HXA |
| Sep 28, 1987 | K872285 | H-H HUNTER ACTIVE TENDON IMPLANT DC Holter-Hausner Intl. | HXA |
| Sep 28, 1987 | K872284 | H-H HUNTER ACTIVE TENDON IMPLANT PC Holter-Hausner Intl. | HXA |
| Sep 30, 1985 | K853438 | H-H HUNTER ACTIVE TENDON IMPLANT Holter-Hausner Intl. | HXA |
| Dec 4, 1978 | K781943 | TENDON ROD MODEL OR41PO3-6 Holter-Hausner Intl. | HXA |
| Mar 17, 1978 | K780320 | PASSIVE TENDON IMPLANT Holter-Hausner Intl. | HXA |
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