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

Memphis, TN, US

ONYX MEDICAL LLC appears in FDA device records in Memphis, TN. FDA records list 48 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
48
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 48 510(k) clearances for Onyx Medical LLC between 1990 and 2004. The busiest year on record is 1990, with 26. The most recent is 2004, with 1.

Clearances by year, as a table
510(k) clearance decisions for Onyx Medical LLC, by decision year
YearClearances
199026
199421
20041
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K041679COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHTILYSubstantially Equivalent
K942022FACE-IT SHIELDLYUSubstantially Equivalent
K931690SPOON PLATEHRSSubstantially Equivalent for Some Indications
K934614MINI FRAGMENT PLATEHRSSubstantially Equivalent for Some Indications
K931692T-PLATEHRSSubstantially Equivalent for Some Indications
K931684EPIPHYSIS PLATEHRSSubstantially Equivalent for Some Indications
K931680CANNULATED CANCELLOUS SCREWHWCSubstantially Equivalent for Some Indications
K934616CANCELLOUS BONE SCREWHWCSubstantially Equivalent for Some Indications
K934615CANCELLOUS BONE SCREWHWCSubstantially Equivalent for Some Indications
K931790CORTICAL BONE SCREWHWCSubstantially Equivalent for Some Indications
K9316941/4 TUBULAR PLATEHRSSubstantially Equivalent for Some Indications
K9316931/3 TUBULAR PLATEHRSSubstantially Equivalent for Some Indications
K931691STRAIGHT MINI-PLATEHRSSubstantially Equivalent for Some Indications
K931689SMALL STRAIGHT PLATEHRSSubstantially Equivalent for Some Indications
K931688SEMI-TUBULAR PLATEHRSSubstantially Equivalent for Some Indications
K931687MULTIPLE FRAGMENT PLATEHRSSubstantially Equivalent for Some Indications
K931685FOREARM SELF COMPRESSION PLATEHRSSubstantially Equivalent for Some Indications
K931683CLOVERLEAF PLATEHRSSubstantially Equivalent for Some Indications
K931681CANNULATED NAVICULAR SCREWHWCSubstantially Equivalent for Some Indications
K931679BUTTRESS PLATEHRSSubstantially Equivalent for Some Indications
K931686MALLEOLAR SCREWKTWSubstantially Equivalent
K931682CANNULATED MALLEOLAR SCREWKWKSubstantially Equivalent for Some Indications
K903259KNOWLES PINHWCSubstantially Equivalent for Some Indications
K903258HAGIE PINHWCSubstantially Equivalent for Some Indications
K903255CORTICAL BONE SCREW (EUROPEAN STYLE)HWCSubstantially Equivalent for Some Indications
K903254U.S. TYPE CRUCIATE SLOT BONE SCREWHWCSubstantially Equivalent for Some Indications
K903253CANCELLOUS SCREWHWCSubstantially Equivalent for Some Indications
K903252BROAD SELF-COMPRESSING PLATEHRSSubstantially Equivalent for Some Indications
K903022FIXATION STAPLEJDRSubstantially Equivalent
K903273BARBED SQUARE STAPLEJDRSubstantially Equivalent
K903271ROUND STAPLEJDRSubstantially Equivalent
K903270T-HANDLE HEX WRENCHLXHSubstantially Equivalent
K903266STEINMAN PIN, THREADJDWSubstantially Equivalent
K903265STEINMAN PINHTYSubstantially Equivalent
K903264K-WIREHTYSubstantially Equivalent
K903261RUSH PINJDWSubstantially Equivalent
K903257DRIVER/EXTRACTORLXHSubstantially Equivalent
K903256HANSEN-STREET TYPE INTRAMEDULLARY NAILHSBSubstantially Equivalent
K903251JEWETT HIP NAILKTTSubstantially Equivalent
K903250BLADE PLATEKTTSubstantially Equivalent
K903248COMBINATION REAMERHTOSubstantially Equivalent
K903247ADJUSTABLE ANGLE GUIDELXHSubstantially Equivalent
K903246SIDE PLATEKTTSubstantially Equivalent
K903244LAG SCREWHWCSubstantially Equivalent
K903243MULLER-TYPE FEMORAL COMPONENTJDISubstantially Equivalent
K903242ACETABULAR CUPJDISubstantially Equivalent
K903241AUSTIN MOORE TYPE HIP PROSTHESISKWLSubstantially Equivalent
K903240THOMPSON TYPE HIS PROSTHESISKWLSubstantially Equivalent

Registered establishments

FDA registered establishments for Onyx Medical LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
10436531043653ONYX MEDICAL LLC1800 North Shelby Oaks Drive, MEMPHIS, TN 38134 US2026and 58 more, listed in full below

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

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