Product code HXA
- Device name
- Prosthesis, Tendon, Passive
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3025
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243477 | Universal Tendon Spacer | Askorn Medical | 2025-01-10 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 03700751502132 | Universal Tendon Spacer | ASKORN MEDICAL | 2025-04-20 |
| 00840420130686 | SWANSON | WRIGHT MEDICAL TECHNOLOGY, INC. | 2016-09-17 |
| 00840420188373 | SWANSON | WRIGHT MEDICAL TECHNOLOGY, INC. | 2016-09-17 |
| 00840420188380 | SWANSON | WRIGHT MEDICAL TECHNOLOGY, INC. | 2016-09-17 |
| 00840420188397 | SWANSON | WRIGHT MEDICAL TECHNOLOGY, INC. | 2016-09-17 |
| 00840420188403 | SWANSON | WRIGHT MEDICAL TECHNOLOGY, INC. | 2016-09-17 |
| 00840420188410 | SWANSON | WRIGHT MEDICAL TECHNOLOGY, INC. | 2016-09-17 |
| 00840420197795 | SWANSON | WRIGHT MEDICAL TECHNOLOGY, INC. | 2016-09-17 |
| 00840420130679 | SWANSON | WRIGHT MEDICAL TECHNOLOGY, INC. | 2016-09-17 |
| 00840420130662 | SWANSON | WRIGHT MEDICAL TECHNOLOGY, INC. | 2016-09-17 |
| 00840420130693 | SWANSON | WRIGHT MEDICAL TECHNOLOGY, INC. | 2016-09-17 |
| M209100930 | TARA FEMORAL COMPONENT 55 | BIOPRO, INC. | 2016-01-08 |
| 00840420132185 | HUNTER | WRIGHT MEDICAL TECHNOLOGY, INC. | 2015-10-15 |
| 00840420132147 | HUNTER | WRIGHT MEDICAL TECHNOLOGY, INC. | 2015-10-15 |
| 00840420132154 | HUNTER | WRIGHT MEDICAL TECHNOLOGY, INC. | 2015-10-15 |
| 00840420132161 | HUNTER | WRIGHT MEDICAL TECHNOLOGY, INC. | 2015-10-15 |
| 00840420132178 | HUNTER | WRIGHT MEDICAL TECHNOLOGY, INC. | 2015-10-15 |
| 00840420121868 | HUNTER | WRIGHT MEDICAL TECHNOLOGY, INC. | 2015-10-15 |
| 00840420132208 | HUNTER | WRIGHT MEDICAL TECHNOLOGY, INC. | 2015-10-15 |
| 00840420132215 | HUNTER | WRIGHT MEDICAL TECHNOLOGY, INC. | 2015-10-15 |
| 00840420132222 | HUNTER | WRIGHT MEDICAL TECHNOLOGY, INC. | 2015-10-15 |
| 00840420121882 | HUNTER | WRIGHT MEDICAL TECHNOLOGY, INC. | 2015-10-15 |
| 00840420121875 | HUNTER | WRIGHT MEDICAL TECHNOLOGY, INC. | 2015-10-15 |
| 00840420121851 | HUNTER | WRIGHT MEDICAL TECHNOLOGY, INC. | 2015-10-15 |
| 00840420132192 | HUNTER | WRIGHT MEDICAL TECHNOLOGY, INC. | 2015-10-15 |
| 00840420121615 | SWANSON | WRIGHT MEDICAL TECHNOLOGY, INC. | 2015-10-01 |
| 00840420121608 | SWANSON | WRIGHT MEDICAL TECHNOLOGY, INC. | 2015-10-01 |
| 00840420121592 | SWANSON | WRIGHT MEDICAL TECHNOLOGY, INC. | 2015-10-01 |
| 00840420121585 | SWANSON | WRIGHT MEDICAL TECHNOLOGY, INC. | 2015-10-01 |
| 00840420121578 | SWANSON | WRIGHT MEDICAL TECHNOLOGY, INC. | 2015-10-01 |