510(k) K243477
- Device
- Universal Tendon Spacer
- Applicant
- Askorn Medical
- 510(k) number
- K243477
- Product code
- HXA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-01-10
- Date received
- 2024-11-08
- Regulation
- 888.3025
- Classification name
- Prosthesis, Tendon, Passive
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Denis Pichon
- Address
- 44c Rue De Bray Cesson-Sévigné FR 35510 35510
FDA Registration Numbers#
- 1043534
- 3008880500
- 3036756245
- 3006017180
- 1061771
- 3010462278
- 3033509898
- 3010667733
- 3025603301
- 2090040
Source Documents#
Other 510(k) Records For Product Code HXA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K000019 | SINGLE SIZE TENDON SPACER | Medist International | 2000-03-29 |
| K973385 | OVAL SHAPES | Technical Products, Inc. | 1997-12-05 |
| K964359 | AVANTA ORTHOPAEDICS TENDON SPACER | Avanta Orthopaedics, Inc. | 1997-03-25 |
| K930125 | PHOENIX BONE SCREWS PBS-TYPE SERIES | Phoenix Bioengineering, Inc. | 1993-12-30 |
| K872284 | H-H HUNTER ACTIVE TENDON IMPLANT PC | Holter-Hausner Intl. | 1987-09-28 |
| K872285 | H-H HUNTER ACTIVE TENDON IMPLANT DC | Holter-Hausner Intl. | 1987-09-28 |
| K872293 | H-H HUNTER ACTIVE TENDON IMPLANT BC | Holter-Hausner Intl. | 1987-09-28 |
| K853438 | H-H HUNTER ACTIVE TENDON IMPLANT | Holter-Hausner Intl. | 1985-09-30 |
| K781943 | TENDON ROD MODEL OR41PO3-6 | Holter-Hausner Intl. | 1978-12-04 |
| K780320 | PASSIVE TENDON IMPLANT | Holter-Hausner Intl. | 1978-03-17 |