510(k) K172104
K172104 is an FDA 510(k) premarket notification submitted by K2M, Inc. for the device "Ozark(tm) Cervical Plate System". The FDA issued a decision of Substantially Equivalent on Aug 23, 2017. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. K2M, Inc. has 123 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 23, 2017
- Date Received
- Jul 12, 2017
- Clearance Type
- Traditional
- 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)