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

Osteo AG — Predicate Candidate Screening

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

73 daysmedian FDA review time

357 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K933340	OSTEO INTERLOCKING-COMPRESSION NAIL	Osteo AG	1994-06-30	357
K922196	OSTEO TIBIA NAIL	Osteo AG	1992-07-23	73
K922193	OSTEO KIRSCHNER WIRE	Osteo AG	1992-07-23	73
K922194	OSTEO STEINMANN PIN	Osteo AG	1992-07-23	73
K922195	OSTEO FEMORAL NAIL	Osteo AG	1992-07-23	73
K920149	OSTEO EX-FI-RE	Osteo AG	1992-04-09	90
K920037	OSTEO COMPRESSION HIP SCREW	Osteo AG	1992-03-11	65
K914374	OSTEO CERCLAGE WIRE	Osteo AG	1991-12-30	90
K913559	OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR	Osteo AG	1991-11-07	90

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