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VQ Orthocare

Vista, CA, US

VQ ORTHOCARE appears in FDA device records in Vista, CA. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
6
PMA records
0
Recall records
6
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to VQ Orthocare carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Apex Surgical, LLC510(k), recall

510(k) clearance history

FDA records hold 6 510(k) clearances for VQ Orthocare between 2000 and 2005. The busiest year on record is 2001, with 2. The most recent is 2005, with 1.

Clearances by year, as a table
510(k) clearance decisions for VQ Orthocare, by decision year
YearClearances
20001
20012
20031
20041
20051
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K043123APEX MODULAR HA HIP STEMLPHSubstantially Equivalent
K041950APEX K2 HIP SYSTEMLPHSubstantially Equivalent
K031110APEX MODULAR ACETABULAR CUPLPHSubstantially Equivalent
K012918APEX MODULAR ALUMINA FEMORAL HEADLZOSubstantially Equivalent
K003923APEX MODULAR ZIRCONIA FEMORAL HEADLZOSubstantially Equivalent
K000788APEX MODULAR HIP STEMLPHSubstantially Equivalent

Registered establishments

FDA registered establishments for VQ Orthocare, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
20318233002757749VQ ORTHOCARE1390 Decision St Ste A, VISTA, CA 92081 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0718-04Apex Pilot Shaft 17.5mmPilot shaft may break during reaming or broaching of the femurTerminated
Z-0717-04Apex Pilot Shaft 16mmPilot shaft may break during reaming or broaching of the femurTerminated
Z-0716-04Apex Pilot Shaft 14.4mmPilot shaft may break during reaming or broaching of the femurTerminated
Z-0715-04Apex Pilot Shaft 13mmPilot shaft may break during reaming or broaching of the femurTerminated
Z-0714-04Apex Pilot Shaft, 11.5mmPilot shaft may break during reaming or broaching of the femurTerminated
Z-0713-04Apex Pilot Shaft, 10mmPilot shaft may break during reaming or broaching of the femurTerminated

Verification record

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