510(k) K950011
K950011 is an FDA 510(k) premarket notification submitted by Cohort Medical Products Group, Inc. for the device "COHORT(TM) ANTERIOR PLATE SYSTEM (APS)". The FDA issued a decision of SN on November 6, 1995. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Cohort Medical Products Group, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- November 6, 1995
- Date Received
- January 3, 1995
- 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