SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System— 510(k) K180156
Substantially EquivalentGlobus Medical, Inc.
FDA 510(k) clearance K180156 for SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System, Substantially Equivalent on 2018-03-07. Applicant: Globus Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Globus Medical, 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
- Audubon, PA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.