UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM)— 510(k) K132968
Substantially EquivalentStryker Spine
FDA 510(k) clearance K132968 for UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM), Substantially Equivalent on 2013-11-18. Applicant: Stryker Spine. Device class: 2.
Clearance details
- Applicant
- Stryker Spine
- Product code
- Product code PEK
- Device class
- Class 2
- Regulation
- 21 CFR 888.3050
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Allendale, NJ, US
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