510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K953599Substantially Equivalent for Some Indications

Clamp Assembly

J.B.S., S.A., Pleasenton CA / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K953599 is the FDA 510(k) clearance record for CLAMP ASSEMBLY, a class II device, cleared for J.B.S., S.A. on under FDA product code KWP (Appliance, Fixation, Spinal Interlaminal). FDA records list 3 510(k) clearances for J.B.S., S.A., from to . As of , FDA records show no recalls naming K953599.

Clearance record

Decision date
Received
(139 days to decision)
Product code
KWP Appliance, Fixation, Spinal Interlaminal
Regulation
21 CFR 888.3050
Device class
Class II
Review panel
Orthopedic
Applicant
J.b.s., S.a. 6311 Shorewood Ct., Pleasenton CA
Third party review
No

Clearances, product code KWP

Trailing 12 months

FDA records hold no clearances under product code KWP in the trailing twelve months.

FDA records show no clearances under product code KWP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KWP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260