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

Dallas, TX, US

Howmedica Leibinger, Inc. appears in FDA device records in Dallas, TX. FDA records list 11 510(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
11
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 11 510(k) clearances for Howmedica Leibinger, Inc. between 1996 and 1997. The busiest year on record is 1997, with 9. The most recent is 1997, with 9.

Clearances by year, as a table
510(k) clearance decisions for Howmedica Leibinger, Inc., by decision year
YearClearances
19962
19979
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K970912LEIBINGER SELF-DRILLING SCREWHWCSubstantially Equivalent
K972166GUERRERO - BELL DISTRACTORJEYSubstantially Equivalent
K972154COHEN DISTRACTORJEYSubstantially Equivalent
K961719EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESESHRSSubstantially Equivalent
K970911LEE PLATEJEYSubstantially Equivalent
K963030LEIBINGER IMF SCREWDZESubstantially Equivalent
K963741LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL BONE SCREWSHRSSubstantially Equivalent
K964649VAZQUEZ DINER INTRAORAL DISTRACTION DEVICEJEYSubstantially Equivalent
K963739LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWSHWCSubstantially Equivalent for Some Indications
K963740LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWSJEYSubstantially Equivalent
K961120MARKER SYSTEM FOR STEREOTAXIC NAVIGATIONHAWSubstantially 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

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