UNiTi ACDF Implant System— 510(k) K200301
Substantially EquivalentPressio, Inc.
FDA 510(k) clearance K200301 for UNiTi ACDF Implant System, Substantially Equivalent on 2021-02-03. Applicant: Pressio, Inc.. Device class: 2.
Clearance details
- Applicant
- Pressio, Inc.
- Product code
- Code PHQ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3060
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Antonio, TX, US
Recent devices under product code PHQ
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