H-H HUNTER PASSIVE TENDON IMPLANT
FDA 510(k) clearance K853436 · decided 1985-10-16
Clearance details
- K-number
- K853436
- Device name
- H-H HUNTER PASSIVE TENDON IMPLANT
- Applicant
- Holter-Hausner Intl.
- Decision
- Substantially Equivalent
- Date received
- 1985-08-15
- Decision date
- 1985-10-16
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- HXR
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Bridgeport, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Holter-Hausner Intl.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400 (K983882) | Micro-Medical Devices, Inc. | 1999-03-15 |
| VIDEO ARTHROSCOPE, 1.7MM X 55 MM (K873387) | Arthropedics, Inc. | 1987-11-25 |
| RAYLOR FUSION FUNNEL (K872281) | Cedar Surgical, Inc. | 1987-11-02 |
Recalls involving this device
No recalls on record reference this clearance.