510(k) K942432
K942432 is an FDA 510(k) premarket notification submitted by J.B.S., S.A. for the device "J.B.S. CERVICAL SPINE SYSTEM". The FDA issued a decision of Substantially Equivalent for Some Indications on Jul 11, 1995. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. J.B.S., S.A. has 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SN (Substantially Equivalent for Some Indications)
- Decision Date
- Jul 11, 1995
- Date Received
- May 20, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appliance, Fixation, Spinal Interlaminal
- Device Class
- Class II
- Regulation Number
- 888.3050
- Review Panel
- OR
- Submission Type
- 510(k)