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

Warsaw, IN, US

Depuy, Inc. appears in FDA device records in Warsaw, IN. FDA records list 220 510(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
220
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 220

FDA records hold 220 510(k) clearances for Depuy, Inc. between 1984 and 2005. The busiest year on record is 1994, with 24. The most recent is 2005, with 1.

Clearances by year, as a table
510(k) clearance decisions for Depuy, Inc., by decision year
YearClearances
19842
198511
198612
198719
19886
198910
199018
199110
199211
19938
199424
199519
199622
199718
199814
19993
20002
20012
20021
20033
20044
20051
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K043058PINNACLE CONSTRAINED ACETABULAR LINERSKWZSubstantially Equivalent
K042664LPS UPPER EXTREMITYJDCSubstantially Equivalent
K041085LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARYJWHSubstantially Equivalent
K033959LPSJWHSubstantially Equivalent
K040544DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062LPHSubstantially Equivalent
K021478DELTA SHOULDERPHXSubstantially Equivalent
K033329DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMSHSBSubstantially Equivalent
K032151DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYSJWHSubstantially Equivalent
K020541AGILITY ANKLE REVISION PROSTHESISHSNSubstantially Equivalent
K011810ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARINGKROSubstantially Equivalent
K003182ORTHOGENESIS LPS SYSTEMJWHSubstantially Equivalent
K001922DEPUY NEUFLEX PIP FINGERKYJSubstantially Equivalent
K993465DEPUY ACE CALCANEAL PERI-ARTICULAR PLATEHRSSubstantially Equivalent
K991649DEPUY ROCKWOOD CLAVICLE PINJDWSubstantially Equivalent
K991135SOFT TISSUE SUTURE WASHERHTNSubstantially Equivalent
K984158P.F.C. MODULAR PLUS OFFSET TIBIAL TRAYJWHSubstantially Equivalent
K984378DEPUY ACROMED MOSS SPINAL SYSTEMMNISubstantially Equivalent
K983583DEPUY ACROMED MOSS AND MOSS MIAMI SPINAL SYSTEMSKWPSubstantially Equivalent
K982330DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANTFTMSubstantially Equivalent
K982511DEPUY MOTECH MOSS MIAMI SPINAL SYSTEMSKWPSubstantially Equivalent
K982320DEPUY MOTECH MOSS MIAMI SPINAL SYSTEMKWPSubstantially Equivalent
K982900PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREWMAISubstantially Equivalent
K981670DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE INTERFERENCE SCREWHWCSubstantially Equivalent
K980794DUAL LOCK HIP STEMJDISubstantially Equivalent
K980368DEPUY MOTECH PEAK 3MM FIXATION ROD SYSTEMHRSSubstantially Equivalent
K980440DEPUY ORTHOTECH PHANTOM SOF-THREAD SOFT TISSUE INTERFERENCE SCREWHWCSubstantially Equivalent for Some Indications
K974740DEPUY TRI-LOCK HIP STEMLPHSubstantially Equivalent
K974781DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAILHSBSubstantially Equivalent
K974573DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEMKWPSubstantially Equivalent for Some Indications
K972643DEPUY AMK 3 PEG PATELLAJWHSubstantially Equivalent for Some Indications
K972596DEPUY DURALOC ACETABULAR CUP SYSTEMLPHSubstantially Equivalent
K973060DEPUY MOTECH PROFILE ANTERIOR THORACOLUMBAR PLATE SYSTEMKWQSubstantially Equivalent for Some Indications
K971730DEPUY MOTECH PEAK POLYAXIAL ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially Equivalent for Some Indications
K972832PROVISION SURGICAL HELMET SYSTEMFYASubstantially Equivalent
K972629DEPUY AE TK2 HIP SCREW SYSTEMKTTSubstantially Equivalent
K972494DEPUY DUPONT ABSORBABLE SET SCREWHWCSubstantially Equivalent
K972568DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEMMNHSubstantially Equivalent
K970544DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESISKYJSubstantially Equivalent
K970241DEPUY PROXIMAL FEMORAL REPLACEMENT PROSTHESISLPHSubstantially Equivalent
K971742DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINTFMQSubstantially Equivalent
K964650TCP-COATED POROCOAT AML FEMORAL HIP PROSTHESISLPHSubstantially Equivalent
K970929DEPUY LOW PROFILE BONE SCREWHWCSubstantially Equivalent for Some Indications
K964114DEPUY OPTI-CON AND E-Z SHIELD SYSTEMSFXXSubstantially Equivalent
K964024DEPUY MOTECH TITANIUM MOSS MIAMI SPINAL SYSTEMKWPSubstantially Equivalent
K962628MOSS MIAMI SPINAL SYSTEMKWPSubstantially Equivalent for Some Indications
K965145DEPUY MOTECH MOSS MIAMI SPINAL SYSTEMKWPSubstantially Equivalent
K964521DEPUY DUPONT PHANTOM SUTURE ANCHORMAISubstantially Equivalent
K964704DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEMLZOSubstantially Equivalent
K962486DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEMKWQSubstantially Equivalent for Some Indications
K963973DEPUY CANNULATED CROSS PIN SCREW SYSTEMJDWSubstantially 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.

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