510(k) K953599

CLAMP ASSEMBLY by J.B.S., S.A. — Product Code KWP

K953599 is an FDA 510(k) premarket notification submitted by J.B.S., S.A. for the device "CLAMP ASSEMBLY". The FDA issued a decision of Substantially Equivalent for Some Indications on Dec 19, 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
Dec 19, 1995
Date Received
Aug 2, 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 K953599. Report a data issue: hello@regdatalab.com.