510(k) K121060
K121060 is an FDA 510(k) premarket notification submitted by Spinefrontier, Inc. for the device "SPINE FRONTIER INDUS ACP SYSTEM". The FDA issued a decision of Substantially Equivalent on Jul 3, 2012. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Spinefrontier, Inc. has 23 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 3, 2012
- Date Received
- Apr 6, 2012
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Appliance, Fixation, Spinal Intervertebral Body
- Device Class
- Class II
- Regulation Number
- 888.3060
- Review Panel
- OR
- Submission Type
- 510(k)