Polaris Spinal Growth System— 510(k) K180227
Substantially EquivalentZimmer Biomet Spine, Inc.
FDA 510(k) clearance K180227 for Polaris Spinal Growth System, Substantially Equivalent on 2018-03-15. Applicant: Zimmer Biomet Spine, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer Biomet Spine, Inc.
- Product code
- Code PGM
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westminister, CO, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.