SMOOTH STAPLE IMPLANT
FDA 510(k) clearance K900433 · decided 1990-11-16
Clearance details
- K-number
- K900433
- Device name
- SMOOTH STAPLE IMPLANT
- Applicant
- Interphase Implants, Inc.
- Decision
- Unknown
- Date received
- 1990-01-30
- Decision date
- 1990-11-16
- Days to decision
- 290 days
- Clearance type
- Traditional
- Product code
- MDL
- Device class
- 2
- Regulation number
- 872.4760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Livonia, MI, 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 |
|---|---|---|
| ORMCO TRANSMANDIBULAR IMPLANT (K852894) | Ormco Corp. | 1985-08-29 |
Recalls involving this device
No recalls on record reference this clearance.