K2M Growing Spine System— 510(k) K161028
Substantially EquivalentK2m, Inc.
FDA 510(k) clearance K161028 for K2M Growing Spine System, Substantially Equivalent on 2016-07-22. Applicant: K2m, Inc.. Device class: 2.
Clearance details
- Applicant
- K2m, 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
- Leesburg, VA, US
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More clearances from K2m, Inc.
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