510(k) K180227
K180227 is an FDA 510(k) premarket notification submitted by Zimmer Biomet Spine, Inc. for the device "Polaris Spinal Growth System". The FDA issued a decision of Substantially Equivalent on March 15, 2018. The device falls under product code PGM (Growing Rod System), a Class II device regulated under 21 CFR 888.3070. Zimmer Biomet Spine, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 2018
- Date Received
- January 26, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Growing Rod System
- Device Class
- Class II
- Regulation Number
- 888.3070
- Review Panel
- OR
- Submission Type
Stabilization or correction of spinal deformities without the use of fusion.