OVAL SHAPES
FDA 510(k) clearance K973385 · decided 1997-12-05
Clearance details
- K-number
- K973385
- Device name
- OVAL SHAPES
- Applicant
- Technical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-09-08
- Decision date
- 1997-12-05
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- HXA
- Device class
- 2
- Regulation number
- 888.3025
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Decatur, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Universal Tendon Spacer (K243477) | Askorn Medical | 2025-01-10 |
| SINGLE SIZE TENDON SPACER (K000019) | Medist International | 2000-03-29 |
| AVANTA ORTHOPAEDICS TENDON SPACER (K964359) | Avanta Orthopaedics, Inc. | 1997-03-25 |
| PHOENIX BONE SCREWS PBS-TYPE SERIES (K930125) | Phoenix Bioengineering, Inc. | 1993-12-30 |
| H-H HUNTER ACTIVE TENDON IMPLANT DC (K872285) | Holter-Hausner Intl. | 1987-09-28 |
| H-H HUNTER ACTIVE TENDON IMPLANT BC (K872293) | Holter-Hausner Intl. | 1987-09-28 |
| H-H HUNTER ACTIVE TENDON IMPLANT PC (K872284) | Holter-Hausner Intl. | 1987-09-28 |
| H-H HUNTER ACTIVE TENDON IMPLANT (K853438) | Holter-Hausner Intl. | 1985-09-30 |
| TENDON ROD MODEL OR41PO3-6 (K781943) | Holter-Hausner Intl. | 1978-12-04 |
| PASSIVE TENDON IMPLANT (K780320) | Holter-Hausner Intl. | 1978-03-17 |
Recalls involving this device
No recalls on record reference this clearance.