510(k) K873977
K873977 is an FDA 510(k) premarket notification submitted by Sofamor Co. for the device "NEW C-D SYSTEM FOR SPINAL SURGERY". The FDA issued a decision of SN on December 7, 1987. The device falls under product code JDN (Implant, Fixation Device, Spinal), a Class II device regulated under 21 CFR 888.3060. Sofamor Co. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- December 7, 1987
- Date Received
- September 29, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Fixation Device, Spinal
- Device Class
- Class II
- Regulation Number
- 888.3060
- Review Panel
- OR
- Submission Type