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

Depuyacromed — Predicate Candidate Screening

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

30 daysmedian FDA review time

105 days90th percentile

48clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K040197	EAGLE ANTERIOR CERVIAL PLATE SYSTEM	Depuyacromed	2004-04-02	64	0
K031635	DEPUY ACROMED VBR SYSTEM	Depuyacromed	2003-06-23	27	0
K030833	DEPUY ACROMED VBR SYSTEM	Depuyacromed	2003-04-10	24	0
K030383	MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS	Depuyacromed	2003-02-26	21	0
K030249	SURGICAL TITANIUM MESH SYSTEM	Depuyacromed	2003-02-14	21	0
K030103	SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS	Depuyacromed	2003-02-05	23	0
K023835	DEVEX MESH SYSTEM	Depuyacromed	2003-01-29	72	0
K024348	MONARCH SPINE SYSTEM	Depuyacromed	2003-01-28	29	0
K023804	MOSS MIAMI SPINAL SYSTEM PIN NUT	Depuyacromed	2003-01-23	70	0
K021039	BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM	Depuyacromed	2002-12-11	254	0
K023438	MODIFICATION TO MONARCH SPINE SYSTEM	Depuyacromed	2002-11-13	29	0
K022623	5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM)	Depuyacromed	2002-08-27	20	0
K022285	MODIFICATION TO ISOLA SPINAL SYSTEM	Depuyacromed	2002-08-13	29	0
K022246	MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM	Depuyacromed	2002-08-02	21	0
K022190	MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINA	Depuyacromed	2002-07-24	19	0
K021335	MONARCH SPINE SYSTEM	Depuyacromed	2002-07-11	76	0
K021879	CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM)	Depuyacromed	2002-06-26	19	0
K021880	CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM)	Depuyacromed	2002-06-26	19	0
K021148	MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD	Depuyacromed	2002-05-08	28	0
K020522	MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM	Depuyacromed	2002-03-21	30	0
K014053	CONDUIT TCP GRANULES	Depuyacromed	2002-03-08	88	0
K013441	ISOLA POLYAXIAL WASHER	Depuyacromed	2001-11-16	30	0
K012773	DISCOVERY FACET SCREW FIXATION SYSTEM	Depuyacromed	2001-11-16	88	0
K012738	SYMPHONY GRAFT DELIVERY SYSTEM (GDS)	Depuyacromed	2001-11-14	90	0
K013222	SUMMIT OCCIPITO-CERVICO- THORACIC (OCT) SPINAL SYSTEM	Depuyacromed	2001-11-07	41	0
K013382	MODIFICATION TO: STACKABLE CAGE SYSTEM	Depuyacromed	2001-11-07	26	0
K013294	MONARCH SPINAL SYSTEMS	Depuyacromed	2001-10-09	7	0
K013296	MOSS MIAMI SPINAL SYSTEMS	Depuyacromed	2001-10-09	7	0
K013295	TIMX SPINAL SYSTEMS	Depuyacromed	2001-10-09	7	0
K012971	ISOLA SPINAL SYSTEMS	Depuyacromed	2001-10-05	30	0
K010681	SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM	Depuyacromed	2001-07-18	133	0
K010972	ISOLA BAND CLAMP	Depuyacromed	2001-06-12	71	0
K010576	MONARCH SPINE SYSTEM	Depuyacromed	2001-05-23	85	0
K011182	MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS	Depuyacromed	2001-05-16	28	0
K003043	SURGICAL TITANIUM MESH SYSTEM	Depuyacromed	2001-05-08	221	0
K010742	MOSS MIAMI 5.5MM TITANIUM PIN NUT	Depuyacromed	2001-04-12	30	0
K010320	MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM	Depuyacromed	2001-03-01	27	0
K003286	SYMPHONY GRAFT DELIVERY SYSTEM	Depuyacromed	2001-01-18	90	0
K003822	ISOLA CLOSED DUAL ROD CONNECTOR	Depuyacromed	2001-01-08	28	0
K002733	SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM	Depuyacromed	2000-12-15	105	0
K002607	MOSS MIAMI 6.35MM ROD SYSTEM MONOAXIAL SCREWS, POLYAXIAL RED	Depuyacromed	2000-09-12	21	0
K001470	E-Z LINK CROSS CONNECTOR	Depuyacromed	2000-08-04	85	0
K001372	E-Z LINK CROSS CONNECTOR	Depuyacromed	2000-07-27	87	0
K001340	STACKABLE CAGE SYSTEM	Depuyacromed	2000-07-26	90	0
K001105	MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS	Depuyacromed	2000-04-24	19	0
K993030	MODIFICATION TO ISOLA SPINAL SYSTEM	Depuyacromed	1999-12-29	113	0
K993099	BREMER HALO SYSTEM TITANIUM SKULL PIN	Depuyacromed	1999-12-15	90	15
K992168	MOSS MIAMI 6.35MM POLYAXIAL SCREW	Depuyacromed	1999-09-23	87	0

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