510(k) K181068
K181068 is an FDA 510(k) premarket notification submitted by Globus Medical, Inc. for the device "CREO® Stabilization System, REVERE® Stabilization System". The FDA issued a decision of Substantially Equivalent on June 29, 2018. The device falls under product code PGM (Growing Rod System), a Class II device regulated under 21 CFR 888.3070. Globus Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 29, 2018
- Date Received
- April 23, 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.