SPLINH, FOREARM
FDA 510(k) clearance K770891 · decided 1977-05-26
Clearance details
- K-number
- K770891
- Device name
- SPLINH, FOREARM
- Applicant
- Orthopedic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-05-16
- Decision date
- 1977-05-26
- Days to decision
- 10 days
- Clearance type
- Traditional
- Product code
- IQM
- Device class
- 1
- Regulation number
- 890.3025
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Mchenry, IL, 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 |
|---|---|---|
| FINGEO EXTENSION SPLINTS (K771287) | Fred Sammons, Inc. | 1977-07-21 |
| SPLINT, COCKUP (K770890) | Orthopedic Systems, Inc. | 1977-05-26 |
Recalls involving this device
No recalls on record reference this clearance.