Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

GEG — Predicate Candidate Screening

12 FDA 510(k) clearances under this product code; the 50 most recent screened below.

19 daysmedian FDA review time

35 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K891899	ELEVATORS, VARIOUS TYPES	Zinnanti Surgical Instruments, Inc.	1989-04-12	19
K891894	ELEVATORS-COTTLE,MCKENTY,GOLDMAN,JOSEPH,CONVERSE	Zinnanti Surgical Instruments, Inc.	1989-04-12	19
K890365	SEPTUM ELEVATOR	Kinetic Medical Products	1989-02-03	11
K890253	SURGICAL ELEVATOR	Kinetic Medical Products	1989-01-27	9
K890230	LIGATURE NEEDLES	Kinetic Medical Products	1989-01-27	9
K872491	1.1 TWIST DRILLS AND 1.2 CORTICAL DRILLS	Micro-Aire Surgical Instruments, Inc.	1987-07-16	23
K870781	ACROMED WALLIE-HEINIG DISECTOR/ELEVATORS	Buckman Co., Inc.	1987-03-09	11
K870591	ELEVATOR, COBB SPINAL	Military Engineering, Inc.	1987-02-26	16
K870126	FEMUR WRENCH	Orthopedic Systems, Inc.	1987-02-03	22
K864421	RAYLOR(TM) PERIOSTEAL ELEVATORS	Cedar Surgical, Inc.	1986-11-26	16
K834176	H.R. JAKOBI SURG. INSTRUMENTS 40/41	Imm Enterprises , Ltd.	1984-01-27	67
K781449	HARRINGTON SPINAL ELEVATOR	Orthopedic Equipment Co., Inc.	1978-09-27	35

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