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

Camarillo, CA, US

KINAMED, INC. appears in FDA device records in Camarillo, CA. FDA records list 33 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
33
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 33 510(k) clearances for Kinamed Inc between 1988 and 2013. The busiest year on record is 1992, with 6. The most recent is 2013, with 1.

Clearances by year, as a table
510(k) clearance decisions for Kinamed Inc, by decision year
YearClearances
19881
19892
19905
19913
19926
19941
19952
19971
19981
20001
20012
20022
20032
20041
20051
20071
20131
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K122049NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEMGWOSubstantially Equivalent
K072250SUPERCABLE GRIP AND PLATE SYSTEMKTTSubstantially Equivalent
K050897NAVIPRO SHOULDER SOFTWARE MODULEHAWSubstantially Equivalent
K033668NAVIPRO KNEE SOFTWARE MODULEHAWSubstantially Equivalent
K032950GEM INSET PATELLAR COMPONENTJWHSubstantially Equivalent
K030256ISO-ELASTIC CERCLAGE SYSTEMJDQSubstantially Equivalent
K020764NAVIPROHAWSubstantially Equivalent
K013982KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANTKRRSubstantially Equivalent
K010101GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEMJWHSubstantially Equivalent
K003347ORTHOPILOTHAWSubstantially Equivalent
K994214GEM KNEE SYSTEMJWHSubstantially Equivalent
K982927QUICK TAP SELF DRILLING SCREWDZLSubstantially Equivalent
K964362KINAMED PROFIX SYSTEMHRSSubstantially Equivalent
K954219REALITY LONG STEM HIP SYSTEMJDISubstantially Equivalent
K954213ATH FULL PROFILE ACETABULAR CUP SYSTEMLPHSubstantially Equivalent
K922247KINAMED REALITY TOTAL HIP SYSTEMLZOSubstantially Equivalent
K920290KINAMED 32MM BIOCERAM-Z TOATAL HIP FEMORAL BALLLZOSubstantially Equivalent
K920219KINAMED 26MM BIOCERAN-Z TOTAL HIP FEMORAL BALLLZOSubstantially Equivalent
K922421KINAMED ATH-POROUS AND ATH-POROUS LONG TOTAL HIPJDISubstantially Equivalent
K915310KINAMED 28MM BIOCERAM-Z TOTAL HIP FEMORAL BALLLZOSubstantially Equivalent
K915309KINAMED 22MM BIOCERAM-Z TOTAL HIP FEMORAL BALLLZOSubstantially Equivalent
K914843KINAMED ATH-HA & ATH-HA LONG TOTAL HIPMEHSubstantially Equivalent
K914237KINAMED CTN STEMLZOSubstantially Equivalent
K912295KINAMED ATH 28MM ALUMINA CERAMIC LONG-NECK BALLLZOSubstantially Equivalent
K903976CTH STABILO TOTAL HIP REPLACEMENT SYSTEMLZOSubstantially Equivalent
K903885KINAMED ATH 22MM COCR TOTAL HLIP FEMORAL HEADKWLSubstantially Equivalent
K903884KINAMED ATH 26MM COCR TOTAL HIP FEMORAL HEADKWLSubstantially Equivalent
K902074KINAMED CEMENTED CTH STEMLZOSubstantially Equivalent for Some Indications
K902073KINAMED CEMENTED ATH-LONG STEMLZOSubstantially Equivalent
K894904KINAMED CERAMIC ATH TOTAL HIP - 28MM BALLLZOSubstantially Equivalent for Some Indications
K893821ACETABULAR SHELLS & LINERS FOR ATH TOTAL HIP SYST.JDISubstantially Equivalent
K890472ATH CERAMIC UHMWPE TOTAL HIP SYSTEMLZOSubstantially Equivalent for Some Indications
K882675ATH METAL:UHMWPE TOTAL HIP SYSTEMKWASubstantially Equivalent for Some Indications

Registered establishments

FDA registered establishments for Kinamed Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
20271482027148KINAMED, INC.820 Flynn Rd, CAMARILLO, CA 93012 US2026and 3 more, listed in full below

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-2588-2011Kinamed SuperCable Grip and Plate System Driver, 3.5mm Hex, Catalog Number: 35-860-2060 The driver is intended to be used in conjunction with compression and locking bone screws for fixation of long bone fractures when Kinamed Trochanteric Grips & Cable-Plates are used. Subsequent Product Codes: HWC, JDQ.The recall was initiated due to inadequate mechanical strength of these screwdrivers' hexagonal tip feature, causing it to strip during final tightening.Terminated

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.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

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