510(k) K955864

J.B. S. C1-C2 CLAMP by J.B.S., S.A. — Product Code KWP

K955864 is an FDA 510(k) premarket notification submitted by J.B.S., S.A. for the device "J.B. S. C1-C2 CLAMP". The FDA issued a decision of Substantially Equivalent on Mar 15, 1996. 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
SESE (Substantially Equivalent)
Decision Date
Mar 15, 1996
Date Received
Dec 27, 1995
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)

Source: FDA 510(k) database entry for K955864. Report a data issue: hello@regdatalab.com.