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

Austin, TX, US

Encore Orthopedics, Inc. appears in FDA device records in Austin, TX. FDA records list 85 510(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
85
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 85

FDA records hold 85 510(k) clearances for Encore Orthopedics, Inc. between 1993 and 2004. The busiest year on record is 2000, with 12. The most recent is 2004, with 1.

Clearances by year, as a table
510(k) clearance decisions for Encore Orthopedics, Inc., by decision year
YearClearances
19931
199410
199511
199610
199710
19988
199910
200012
20016
20026
20041
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K0329053DKNEE POROUS COATED FEMORAL COMPONENTMBHSubstantially Equivalent
K0201143D KNEEJWHSubstantially Equivalent
K020741UNICONDYLAR KNEEHRYSubstantially Equivalent
K020236MODIFICATION TO PASS SPINAL SYSTEMKWPSubstantially Equivalent
K020170KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UPLPHSubstantially Equivalent
K013490CEMENTED CALCAR HIP SYSTEMLPHSubstantially Equivalent
K013442PASS SPINAL SYSTEMKWPSubstantially Equivalent
K003324PLASMA SPRAYED SHOULDERKWSSubstantially Equivalent
K013431PASS SPINAL SYSTEMMNISubstantially Equivalent
K013191PASS SPINAL SYSTEMMNISubstantially Equivalent
K011856RADIOGRAPHIC MARKERSNEUSubstantially Equivalent
K012175PASS SPINAL SYSTEMMNISubstantially Equivalent
K003250FMP METAL/METAL ACETABULAR INSERTKWASubstantially Equivalent
K002941ACETABULAR PLATESLWJSubstantially Equivalent
K002959MODIFICATION TO ISOBAR SPINAL SYSTEMKWPSubstantially Equivalent
K001847ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially Equivalent
K001024PASS SPINAL SYSTEMMNHSubstantially Equivalent
K000590LATERAL PIVOT INSERTJWHSubstantially Equivalent
K000521KEYSTONE HIPLPHSubstantially Equivalent
K993841CEMSTOP CEMENT RESTRICTORLZNSubstantially Equivalent
K993630BIOLOK SCREWHWCSubstantially Equivalent
K000425ISOBAR SPINAL SYSTEMMNISubstantially Equivalent
K993943ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH HA, ENCORE REVELATION POROUS HIP WITH HAMEHSubstantially Equivalent
K000020MODIFICATION TO ISOBAR SPINAL SYSTEMMNHSubstantially Equivalent
K994070REVELATION POROUS HIP STEMLPHSubstantially Equivalent
K992738ISOBAR SPINAL SYSTEMMNISubstantially Equivalent
K992109ENCORE FULLY COATED HIPLPHSubstantially Equivalent
K991889ULTIMAX HAIG II NAIL SYSTEMLXTSubstantially Equivalent
K991790ULTIMAX ANKLE FUSION ROD SYSTEMHSBSubstantially Equivalent
K991603GRIT BLASTED HUMERAL STEMKWTSubstantially Equivalent
K991325MODIFICATION OF ENCORE LINEAR POROUS COATED HIPLPHSubstantially Equivalent
K9912278MM FORGED CEMENTED STEMJDISubstantially Equivalent
K991226FOUNDATION POROUS HIP STEMLZOSubstantially Equivalent
K982160HINGED KNEEKROSubstantially Equivalent
K982663STIMULAN- CALCIUM SULFATE BONE VOID FILLERMQVSubstantially Equivalent
K980854RETROGRADE PEDIATRIC NAILHTYSubstantially Equivalent
K980473PRESS-FIT STEMLZOSubstantially Equivalent
K974095FOUNDATION POROUS COATED FLARED RIM SHELLLPHSubstantially Equivalent
K974093FOUNDATION POROUS COATED HEMISPHERICAL SHELLLPHSubstantially Equivalent
K973119FOUNDATION POROUS ACETABULAR SYSTEMLPHSubstantially Equivalent
K974294ENCORE LINEAR POROUS COATED HIPLPHSubstantially Equivalent
K972791ENCORE LINEAR HIPJDISubstantially Equivalent for Some Indications
K973809FOUNDATION FRACTURE STEMJDISubstantially Equivalent
K973685REVELATION POROUS HIP STEMLPHSubstantially Equivalent
K973672FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLAJWHSubstantially Equivalent for Some Indications
K973614FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVESKWLSubstantially Equivalent
K973302FOUNDATION POROUS HIP STEMLPHSubstantially Equivalent
K965002ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL ANDLZOSubstantially Equivalent
K964178PRESS-FIT HIP STEMLWJSubstantially Equivalent
K970031FOUNDATION KNEE SYSTEM TIBIAL COMPONENTJWHSubstantially 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.

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