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

Ortho Tec, LLC — Predicate Candidate Screening

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

90 daysmedian FDA review time

262 days90th percentile

22clearances measured

K-number	Device	Applicant	Decided	Review days
K040514	EOVIA CALCIUM PHOSPHATE CERAMIC	Ortho Tec, LLC	2004-05-03	66
K040346	MODIFICATION TO ORIA TOP CLIP SYSTEM	Ortho Tec, LLC	2004-03-12	29
K030958	ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS	Ortho Tec, LLC	2003-11-20	238
K031471	ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MOD	Ortho Tec, LLC	2003-10-10	154
K023884	MODIFICATION ORIA SPINAL SYSTEM	Ortho Tec, LLC	2003-08-20	272
K023378	ORIA CLARIS	Ortho Tec, LLC	2003-06-27	262
K031452	ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND A	Ortho Tec, LLC	2003-06-18	42
K030500	ORIA ZENITH	Ortho Tec, LLC	2003-03-20	29
K023377	ORIA CERVICAL PLATES	Ortho Tec, LLC	2003-03-04	147
K030253	ORIA SPINAL CLIP SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL	Ortho Tec, LLC	2003-02-21	28
K030252	ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05	Ortho Tec, LLC	2003-02-21	28
K023994	ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ	Ortho Tec, LLC	2003-02-05	64
K021679	ORIA SPINAL CLIP SYSTEM	Ortho Tec, LLC	2002-11-19	182
K021919	SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDI	Ortho Tec, LLC	2002-07-03	22
K021379	SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODE	Ortho Tec, LLC	2002-05-31	30
K011807	SCS CLARIS SPINAL SCREWS, TYPES V,G,E	Ortho Tec, LLC	2001-08-07	57
K003823	SCS DT-02 TRANSVERSE CONNECTOR	Ortho Tec, LLC	2001-07-11	212
K003733	SCS CLOSED SCREW	Ortho Tec, LLC	2001-05-29	176
K010369	CLARIS PLATE SYSTEM	Ortho Tec, LLC	2001-05-08	90
K001535	ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION	Ortho Tec, LLC	2001-03-20	307
K994288	5.0MM SPINAL SCREWS	Ortho Tec, LLC	2000-04-10	112
K993926	OMNIAXIAL CONNECTOR	Ortho Tec, LLC	1999-12-17	29

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