UNiTi ACDF Implant System
FDA 510(k) clearance K200301 · decided 2021-02-03
Clearance details
- K-number
- K200301
- Device name
- UNiTi ACDF Implant System
- Applicant
- Pressio, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-02-06
- Decision date
- 2021-02-03
- Days to decision
- 363 days
- Clearance type
- Traditional
- Product code
- PHQ
- Device class
- 2
- Regulation number
- 888.3060
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Antonio, 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 |
|---|---|---|
| C-JAWS CERVICAL COMPRESSIVE STAPLE (K133906) | Medicrea International | 2014-07-24 |
Recalls involving this device
No recalls on record reference this clearance.