510(k) K853678
K853678 is an FDA 510(k) premarket notification submitted by Pilling Co. for the device "KAMBIN SPINAL INSTRUMENT SET". The FDA issued a decision of Substantially Equivalent on Sep 24, 1985. The device falls under product code HTZ (Instrument, Cutting, Orthopedic), a Class I device regulated under 21 CFR 878.4800. Pilling Co. has 39 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 24, 1985
- Date Received
- Sep 3, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Instrument, Cutting, Orthopedic
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type
- 510(k) Exempt