Spinal Elements' Spinous Process Plate System— 510(k) K160465
Substantially EquivalentSpinal Elements, Inc.
FDA 510(k) clearance K160465 for Spinal Elements' Spinous Process Plate System, Substantially Equivalent on 2016-07-28. Applicant: Spinal Elements, Inc.. Device class: 2.
Clearance details
- Applicant
- Spinal Elements, Inc.
- Product code
- 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
- Carlsbad, CA, US
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