510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Depuyacromed

Raynham, MA, US

Depuyacromed appears in FDA device records in Raynham, MA. FDA records list 48 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
48
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 48 510(k) clearances for Depuyacromed between 1999 and 2004. The busiest year on record is 2001, with 18. The most recent is 2004, with 1.

Clearances by year, as a table
510(k) clearance decisions for Depuyacromed, by decision year
YearClearances
19993
20006
200118
200212
20038
20041
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K040197EAGLE ANTERIOR CERVIAL PLATE SYSTEMKWQSubstantially Equivalent
K031635DEPUY ACROMED VBR SYSTEMMQPSubstantially Equivalent
K030833DEPUY ACROMED VBR SYSTEMMQPSubstantially Equivalent
K030383MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWSMNHSubstantially Equivalent
K030249SURGICAL TITANIUM MESH SYSTEMMQPSubstantially Equivalent
K030103SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWSMNISubstantially Equivalent
K023835DEVEX MESH SYSTEMMQPSubstantially Equivalent
K024348MONARCH SPINE SYSTEMMNHSubstantially Equivalent
K023804MOSS MIAMI SPINAL SYSTEM PIN NUTKWPSubstantially Equivalent
K021039BOWTI ANTERIOR BUTTRESS STAPLE SYSTEMKWQSubstantially Equivalent
K023438MODIFICATION TO MONARCH SPINE SYSTEMMNHSubstantially Equivalent
K0226235.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM)KWPSubstantially Equivalent
K022285MODIFICATION TO ISOLA SPINAL SYSTEMMNISubstantially Equivalent
K022246MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEMFMFSubstantially Equivalent
K022190MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEMMNISubstantially Equivalent
K021335MONARCH SPINE SYSTEMMNHSubstantially Equivalent
K021880CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM)MNHSubstantially Equivalent
K021879CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM)MNHSubstantially Equivalent
K021148MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL RODMNHSubstantially Equivalent
K020522MODIFICATION TO SURGICAL TITANIUM MESH SYSTEMMQPSubstantially Equivalent
K014053CONDUIT TCP GRANULESMQVSubstantially Equivalent
K013441ISOLA POLYAXIAL WASHERKWPSubstantially Equivalent
K012773DISCOVERY FACET SCREW FIXATION SYSTEMMRWSubstantially Equivalent
K012738SYMPHONY GRAFT DELIVERY SYSTEM (GDS)GEYSubstantially Equivalent
K013382MODIFICATION TO: STACKABLE CAGE SYSTEMMQPSubstantially Equivalent
K013222SUMMIT OCCIPITO-CERVICO- THORACIC (OCT) SPINAL SYSTEMMNISubstantially Equivalent
K013296MOSS MIAMI SPINAL SYSTEMSMNHSubstantially Equivalent
K013295TIMX SPINAL SYSTEMSMNHSubstantially Equivalent
K013294MONARCH SPINAL SYSTEMSMNHSubstantially Equivalent
K012971ISOLA SPINAL SYSTEMSMNHSubstantially Equivalent
K010681SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEMKWPSubstantially Equivalent
K010972ISOLA BAND CLAMPMNISubstantially Equivalent
K010576MONARCH SPINE SYSTEMMNISubstantially Equivalent
K011182MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWSMNHSubstantially Equivalent
K003043SURGICAL TITANIUM MESH SYSTEMMQPSubstantially Equivalent
K010742MOSS MIAMI 5.5MM TITANIUM PIN NUTMNHSubstantially Equivalent
K010320MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEMLYCSubstantially Equivalent
K003286SYMPHONY GRAFT DELIVERY SYSTEMLYCSubstantially Equivalent
K003822ISOLA CLOSED DUAL ROD CONNECTORKWPSubstantially Equivalent
K002733SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEMKWPSubstantially Equivalent
K002607MOSS MIAMI 6.35MM ROD SYSTEM MONOAXIAL SCREWS, POLYAXIAL REDUCTION SCREWS AND SACRAL EXTENDERSKWPSubstantially Equivalent
K001470E-Z LINK CROSS CONNECTORKWPSubstantially Equivalent
K001372E-Z LINK CROSS CONNECTORKWPSubstantially Equivalent
K001340STACKABLE CAGE SYSTEMMQPSubstantially Equivalent
K001105MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKSKWPSubstantially Equivalent
K993030MODIFICATION TO ISOLA SPINAL SYSTEMKWQSubstantially Equivalent
K993099BREMER HALO SYSTEM TITANIUM SKULL PINJECSubstantially Equivalent
K992168MOSS MIAMI 6.35MM POLYAXIAL SCREWKWQSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain