Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

J.B.S., S.A. — Predicate Candidate Screening

10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

271 daysmedian FDA review time

417 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K962757	J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONE	J.B.S., S.A.	1996-09-25	71
K955864	J.B. S. C1-C2 CLAMP	J.B.S., S.A.	1996-03-15	79
K953881	SPINE SYSTEM SACRAL PLATE	J.B.S., S.A.	1996-02-21	187
K953599	CLAMP ASSEMBLY	J.B.S., S.A.	1995-12-19	139
K952298	SPINAL PEDICLE SCREW, FIXATION, APPLIANCE	J.B.S., S.A.	1995-12-13	211
K942432	J.B.S. CERVICAL SPINE SYSTEM	J.B.S., S.A.	1995-07-11	417
K940666	JBS SMOOTH FIXATION PIN	J.B.S., S.A.	1994-11-14	271
K940673	J.B.S. SELF-TAPPING THREADED PIN	J.B.S., S.A.	1994-11-14	271
K940669	J.B.S. B.A.C. PIN	J.B.S., S.A.	1994-11-14	271
K935113	J.B.S. IMPLANTABLE SPINAL FIXATION DEVICE	J.B.S., S.A.	1994-10-19	359

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda