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

Cambridge, MA, US

Etex Corp. appears in FDA device records in Cambridge, MA. FDA records list 24 510(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
24
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 24 510(k) clearances for Etex Corp. between 1992 and 2018. The busiest year on record is 2009, with 5. The most recent is 2018, with 1.

Clearances by year, as a table
510(k) clearance decisions for Etex Corp., by decision year
YearClearances
19921
19931
19941
19971
19981
20032
20074
20081
20095
20104
20141
20151
20181
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K182107CarriGen PFMQVSubstantially Equivalent
K132868CARRICELLMQVSubstantially Equivalent
K141245ETEX MIXING AND DELIVERY SYSTEMFMFSubstantially Equivalent
K100883CARRIGENLYCSubstantially Equivalent
K102812GAMMA-BSM; BETA-BSM; EQUIVABONELYCSubstantially Equivalent
K101557GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGENMQVSubstantially Equivalent
K093447CARRIGENMQVSubstantially Equivalent
K091729ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONELYCSubstantially Equivalent
K091607ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONEMQVSubstantially Equivalent
K090855EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTEMQVSubstantially Equivalent
K090310EQUIVABONEMQVSubstantially Equivalent
K090242GAMMA-BSM, BETA-BSMMQVSubstantially Equivalent
K080329CAP PLUS, EQUIVABONE, CAP/DBMMBPSubstantially Equivalent
K063050CAP PLUSMQVSubstantially Equivalent
K072636A-BSM BONE SUBSTITUTE MATERIALMQVSubstantially Equivalent
K072355OSSIFUSE BONE SUBSTITUTE MATERIALMQVSubstantially Equivalent
K062630OSSIPRO BONE SUBSTITUTE MATERIALMQVSubstantially Equivalent
K033138CAP3 BONE SUBSTITUTE MATERIALMQVSubstantially Equivalent
K032307CAP BONE SUBSTITUTE MATERIALGXPSubstantially Equivalent
K983009BSM- BONE SUBSTITUTE MATERIALGXPSubstantially Equivalent
K962548BSM BONE SUBSTITUTE MATERIAL KITLYCSubstantially Equivalent
K935696ETEX HA HIP REPLACEMENT SYSTEMMEHSubstantially Equivalent for Some Indications
K925895ETEX HIP REPLACEMENT SYSTEMJDISubstantially Equivalent
K913417ETEX DENTAL IMPLANT SYSTEMDZESubstantially 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

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

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