NAIL SPLINT
FDA 510(k) clearance K850803 · decided 1985-10-16
Clearance details
- K-number
- K850803
- Device name
- NAIL SPLINT
- Applicant
- Inro Medical Designs, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-02-27
- Decision date
- 1985-10-16
- Days to decision
- 231 days
- Clearance type
- Traditional
- Product code
- MQZ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Desoto, TX, 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 |
|---|---|---|
| NailLift (K230841) | Jps Corporation | 2024-01-22 |
| Oniko nail brace (K162525) | Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti | 2018-04-25 |
| STOP-N-GROW (K960843) | European Touch Co., Inc. | 1996-08-12 |
Recalls involving this device
No recalls on record reference this clearance.