510(k) K161028
K161028 is an FDA 510(k) premarket notification submitted by K2m, Inc. for the device "K2M Growing Spine System". The FDA issued a decision of Substantially Equivalent on July 22, 2016. The device falls under product code PGM (Growing Rod System), a Class II device regulated under 21 CFR 888.3070. K2m, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 2016
- Date Received
- April 12, 2016
- 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.