Oniko nail brace
FDA 510(k) clearance K162525 · decided 2018-04-25
Clearance details
- K-number
- K162525
- Device name
- Oniko nail brace
- Applicant
- Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti
- Decision
- Substantially Equivalent
- Date received
- 2016-09-09
- Decision date
- 2018-04-25
- Days to decision
- 593 days
- Clearance type
- Traditional
- Product code
- MQZ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Cankaya, TR
- 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 |
| STOP-N-GROW (K960843) | European Touch Co., Inc. | 1996-08-12 |
| NAIL SPLINT (K850803) | Inro Medical Designs, Inc. | 1985-10-16 |
Recalls involving this device
No recalls on record reference this clearance.