ClearanceBrief
Product code NRA ยท Class 3

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

0510(k)s in 12 months (0 all time)
0recalls in 12 months (32 all time)
0recalls that name a 510(k)
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Top companies in NRA

Company510(k)sRecalls
Biomet U.K., Ltd.018
Endotec, Inc.013
Biomet, Inc.01
DateFirm and productCodeLinked 510(k)
Jan 5, 2016Biomet U.K., Ltd.
Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size B Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Terminated
NRANone listed
Jan 5, 2016Biomet U.K., Ltd.
Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size B Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Terminated
NRANone listed
Jan 5, 2016Biomet U.K., Ltd.
Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size C Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Terminated
NRANone listed
Jan 5, 2016Biomet U.K., Ltd.
Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size C Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Terminated
NRANone listed
Jan 5, 2016Biomet U.K., Ltd.
Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size D Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Terminated
NRANone listed
Jan 5, 2016Biomet U.K., Ltd.
Oxford Partial Knee System Left Medial Tibial Trial Tray Size B Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Terminated
NRANone listed
Jan 5, 2016Biomet U.K., Ltd.
Oxford Partial Knee System Right Medial Tibial Trial Tray Size B Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Terminated
NRANone listed
Jan 5, 2016Biomet U.K., Ltd.
Oxford Partial Knee System Right Medial Tibial Trial Tray Size C Oxford Partial Knee System Left Medial Tibial Trial Tray Size C
Terminated
NRANone listed
Jan 5, 2016Biomet U.K., Ltd.
Oxford Partial Knee System Right Medial Tibial Trial Tray Size C Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Terminated
NRANone listed
Jan 5, 2016Biomet U.K., Ltd.
Oxford Partial Knee System Left Medial Tibial Trial Tray Size D Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Terminated
NRANone listed
Jan 5, 2016Biomet U.K., Ltd.
Oxford Partial Knee System Right Medial Tibial Trial Tray Size D Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Terminated
NRANone listed
Jan 5, 2016Biomet U.K., Ltd.
Oxford Partial Knee System Left Medial Tibial Trial Tray Size E Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Terminated
NRANone listed
Jan 5, 2016Biomet U.K., Ltd.
Oxford Partial Knee System Right Medial Tibial Trial Tray Size E Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Terminated
NRANone listed
Jan 5, 2016Biomet U.K., Ltd.
Oxford Partial Knee System Left Medial Tibial Trial Tray Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Terminated
NRANone listed
Jan 5, 2016Biomet U.K., Ltd.
Oxford Partial Knee System Right Medial Tibial Trial Tray Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Terminated
NRANone listed
Jan 5, 2016Biomet U.K., Ltd.
Oxford Partial Knee System Left Medial Tibial Trial Tray Size F Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Terminated
NRANone listed
Jan 5, 2016Biomet U.K., Ltd.
Oxford Partial Knee System Right Medial Tibial Trial Tray Size F Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Terminated
NRANone listed
Apr 15, 2013Biomet U.K., Ltd.
REF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found in REF 32-422763 Oxford Mlcroplasty Knee System Tibial instrument Tray small surgical hammer supplied with the Oxford Partia
Terminated
NRANone listed
Jan 11, 2012Endotec, Inc.
"***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 20 Valley Street South Orange NJ, 07079 USA Tel (973)762-6100***Wright Cremascoli Ortho Ltd. Unit 17
Terminated
NRANone listed
Jan 11, 2012Endotec, Inc.
"***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 20 Valley Street South Orange NJ, 07079 USA Tel (973)762-6100***Wright Cremascoli Ortho Ltd. Unit 17
Terminated
NRANone listed
Jan 11, 2012Endotec, Inc.
"***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 20 Valley Street South Orange NJ, 07079 USA Tel (973)762-6100***Wright Cremascoli Ortho Ltd. Unit 17
Terminated
NRANone listed
Jan 11, 2012Endotec, Inc.
"***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 20 Valley Street South Orange NJ, 07079 USA Tel (973)762-6100***Wright Cremascoli Ortho Ltd. Unit 17
Terminated
NRANone listed
Jan 11, 2012Endotec, Inc.
"***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***CAT.NO.***SIZE***" SIZE 3-3X7.5 CAT 04-63
Terminated
NRANone listed
Jan 11, 2012Endotec, Inc.
"***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***CAT.NO.***SIZE***" SIZE 3-3X5 CAT 04-63-2
Terminated
NRANone listed
Jan 11, 2012Endotec, Inc.
"***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***CAT.NO.***SIZE***" SIZE 3-3X2.5 CAT 04-63
Terminated
NRANone listed
Jan 11, 2012Endotec, Inc.
"***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***CAT.NO.***SIZE***" SIZE 3-3X0 CAT 04-63-2
Terminated
NRANone listed
Jan 11, 2012Endotec, Inc.
"***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***" SIZE 1 x 10mm CAT 04-33-0041; SIZE 2 x 10mm C
Terminated
NRANone listed
Jan 11, 2012Endotec, Inc.
"***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***" SIZE 1 x 7.5mm CAT 04-33-0031; SIZE 2 x 7.5mm
Terminated
NRANone listed
Jan 11, 2012Endotec, Inc.
"***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***" SIZE 1 x 5mm CAT 04-33-0021; SIZE 2 x 5mm CAT
Terminated
NRANone listed
Jan 11, 2012Endotec, Inc.
"***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***" SIZE 1 x 2.5mm CAT 04-33-0011; SIZE 2 x 2.5mm
Terminated
NRANone listed
Jan 11, 2012Endotec, Inc.
"***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***" SIZE 1 x 0mm CAT 04-33-0001; SIZE 2 x 0mm CAT
Terminated
NRANone listed
Feb 3, 2009Biomet, Inc.
Biomet Oxford Unicompartmental Knee, Phase 3, Right Medical Tibial Tray, Standard Size B, CoCr, sterile, Biomet UK Ltd, Bridgend, UK; . Unicompartmental knee joint replacement system. Designed to allo
Terminated
NRANone listed

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