Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Size 5 Right Femoral PS
MODAL MANUFACTURING LLC
M-3101-2205
In Commercial Distribution

  • B035M310122051 ()


  • Posterior-stabilized total knee prosthesis
Size 4 Right Femoral PS
MODAL MANUFACTURING LLC
M-3101-2204
In Commercial Distribution

  • B035M310122041 ()


  • Posterior-stabilized total knee prosthesis
Size 3 Right Femoral PS
MODAL MANUFACTURING LLC
M-3101-2203
In Commercial Distribution

  • B035M310122031 ()


  • Posterior-stabilized total knee prosthesis
Size 2 Right Femoral PS
MODAL MANUFACTURING LLC
M-3101-2202
In Commercial Distribution

  • B035M310122021 ()


  • Posterior-stabilized total knee prosthesis
Size 1 Right Femoral PS
MODAL MANUFACTURING LLC
M-3101-2201
In Commercial Distribution

  • B035M310122011 ()


  • Posterior-stabilized total knee prosthesis
Size 6 Left Femoral PS
MODAL MANUFACTURING LLC
M-3101-2106
In Commercial Distribution

  • B035M310121061 ()


  • Posterior-stabilized total knee prosthesis
Size 5 Left Femoral PS
MODAL MANUFACTURING LLC
M-3101-2105
In Commercial Distribution

  • B035M310121051 ()


  • Posterior-stabilized total knee prosthesis
Size 4 Left Femoral PS
MODAL MANUFACTURING LLC
M-3101-2104
In Commercial Distribution

  • B035M310121041 ()


  • Posterior-stabilized total knee prosthesis
Size 3 Left Femoral PS
MODAL MANUFACTURING LLC
M-3101-2103
In Commercial Distribution

  • B035M310121031 ()


  • Posterior-stabilized total knee prosthesis
Size 2 Left Femoral PS
MODAL MANUFACTURING LLC
M-3101-2102
In Commercial Distribution

  • B035M310121021 ()


  • Posterior-stabilized total knee prosthesis
Size 1 Left Femoral PS
MODAL MANUFACTURING LLC
M-3101-2101
In Commercial Distribution

  • B035M310121011 ()


  • Posterior-stabilized total knee prosthesis
Size 6 Right Femoral CR
MODAL MANUFACTURING LLC
M-3101-1206
In Commercial Distribution

  • B035M310112061 ()


  • Cruciate-retaining total knee prosthesis
Size 5 Right Femoral CR
MODAL MANUFACTURING LLC
M-3101-1205
In Commercial Distribution

  • B035M310112051 ()


  • Cruciate-retaining total knee prosthesis
Size 4 Right Femoral CR
MODAL MANUFACTURING LLC
M-3101-1204
In Commercial Distribution

  • B035M310112041 ()


  • Cruciate-retaining total knee prosthesis
Size 3 Right Femoral CR
MODAL MANUFACTURING LLC
M-3101-1203
In Commercial Distribution

  • B035M310112031 ()


  • Cruciate-retaining total knee prosthesis
Size 2 Right Femoral CR
MODAL MANUFACTURING LLC
M-3101-1202
In Commercial Distribution

  • B035M310112021 ()


  • Cruciate-retaining total knee prosthesis
Size 1 Right Femoral CR
MODAL MANUFACTURING LLC
M-3101-1201
In Commercial Distribution

  • B035M310112011 ()


  • Cruciate-retaining total knee prosthesis
Size 6 Left Femoral CR
MODAL MANUFACTURING LLC
M-3101-1106
In Commercial Distribution

  • B035M310111061 ()


  • Cruciate-retaining total knee prosthesis
Size 5 Left Femoral CR
MODAL MANUFACTURING LLC
M-3101-1105
In Commercial Distribution

  • B035M310111051 ()


  • Cruciate-retaining total knee prosthesis
Size 3 Left Femoral CR
MODAL MANUFACTURING LLC
M-3101-1103
In Commercial Distribution

  • B035M310111031 ()


  • Cruciate-retaining total knee prosthesis
Femoral Paddle Instrument, Balance, LSA
Orthalign, Inc.
402472
In Commercial Distribution

  • 00810832031482 ()
402472

  • Orthopaedic surgical procedure kit, non-medicated, reusable
ACF, Distal Femoral Cutting block
ARTHREX, INC.
SP-613-44
In Commercial Distribution

  • 00888867285651 ()
SP-613-44

  • Joint prosthesis implantation kit, reusable
iBalance TKA Locking Femoral Impactor
ARTHREX, INC.
AR-613-49NT
Not in Commercial Distribution

  • 00888867284364 ()
AR-613-49NT

  • Orthopaedic implant impactor, reusable
ACF, Distal Femoral Alignment Guide
ARTHREX, INC.
SP-643-42
In Commercial Distribution

  • 00888867275553 ()
SP-643-42

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Femoral neck cutting guide unslotted
Medacta International SA
01.75.10.0358
In Commercial Distribution

  • 07630542727313 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Femoral neck cutting guide handle
Medacta International SA
01.75.10.0357
In Commercial Distribution

  • 07630542727306 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
EMPHASYS FEMORAL ALUMINUM TRAY INSTRUMENT
DEPUY (IRELAND)
4800-70-020
In Commercial Distribution

  • 10603295524403 ()
480070020

  • Instrument tray, reusable
EMPHASYS FEMORAL BROACH SIZE 12
DEPUY (IRELAND)
4840-12-100
In Commercial Distribution

  • 10603295513803 ()
484012100

  • Orthopaedic broach
EMPHASYS FEMORAL BROACH SIZE 11
DEPUY (IRELAND)
4840-11-100
In Commercial Distribution

  • 10603295513797 ()
484011100

  • Orthopaedic broach
EMPHASYS FEMORAL BROACH SIZE 10
DEPUY (IRELAND)
4840-10-100
In Commercial Distribution

  • 10603295513780 ()
484010100

  • Orthopaedic broach
EMPHASYS FEMORAL BROACH SIZE 9
DEPUY (IRELAND)
4840-09-100
In Commercial Distribution

  • 10603295513773 ()
484009100

  • Orthopaedic broach
EMPHASYS FEMORAL BROACH SIZE 8
DEPUY (IRELAND)
4840-08-100
In Commercial Distribution

  • 10603295513766 ()
484008100

  • Orthopaedic broach
EMPHASYS FEMORAL BROACH SIZE 7
DEPUY (IRELAND)
4840-07-100
In Commercial Distribution

  • 10603295513759 ()
484007100

  • Orthopaedic broach
EMPHASYS FEMORAL BROACH SIZE 6
DEPUY (IRELAND)
4840-06-100
In Commercial Distribution

  • 10603295513742 ()
484006100

  • Orthopaedic broach
EMPHASYS FEMORAL BROACH SIZE 5
DEPUY (IRELAND)
4840-05-100
In Commercial Distribution

  • 10603295513735 ()
484005100

  • Orthopaedic broach
EMPHASYS FEMORAL BROACH SIZE 4
DEPUY (IRELAND)
4840-04-100
In Commercial Distribution

  • 10603295513728 ()
484004100

  • Orthopaedic broach
EMPHASYS FEMORAL BROACH SIZE 3
DEPUY (IRELAND)
4840-03-100
In Commercial Distribution

  • 10603295513711 ()
484003100

  • Orthopaedic broach
EMPHASYS FEMORAL BROACH SIZE 2
DEPUY (IRELAND)
4840-02-100
In Commercial Distribution

  • 10603295513704 ()
484002100

  • Orthopaedic broach
EMPHASYS FEMORAL BROACH SIZE 1
DEPUY (IRELAND)
4840-01-100
In Commercial Distribution

  • 10603295513698 ()
484001100

  • Orthopaedic broach
TUKS, Femoral Starter Reamer, Assy
Shalby Advanced Technologies, Inc.
3000-0-0100
In Commercial Distribution

  • 00840286847537 ()
3000-0-0100

  • Medullary canal orthopaedic reamer, rigid
PS Femoral and Tibial Trials
Shalby Advanced Technologies, Inc.
CKSCASE8
In Commercial Distribution

  • 00840286839426 ()
CKSCASE8

  • Surgical instrument/implant rack
Beaule Femoral Head Sizer 54mm
INNOMED, INC.
4576-54
In Commercial Distribution

  • 00840277132048 ()
4576-54

  • Surgical drill guide, reusable
Beaule Femoral Head Sizer 52mm
INNOMED, INC.
4576-52
In Commercial Distribution

  • 00840277132031 ()
4576-52

  • Surgical drill guide, reusable
Beaule Femoral Head Sizer 50mm
INNOMED, INC.
4576-50
In Commercial Distribution

  • 00840277132024 ()
4576-50

  • Surgical drill guide, reusable
Beaule Femoral Head Sizer 48mm
INNOMED, INC.
4576-48
In Commercial Distribution

  • 00840277132017 ()
4576-48

  • Surgical drill guide, reusable
Beaule Femoral Head Sizer 46mm
INNOMED, INC.
4576-46
In Commercial Distribution

  • 00840277132000 ()
4576-46

  • Surgical drill guide, reusable
Beaule Femoral Head Sizer 44mm
INNOMED, INC.
4576-44
In Commercial Distribution

  • 00840277131997 ()
4576-44

  • Surgical drill guide, reusable
Beaule Femoral Head Sizer 42mm
INNOMED, INC.
4576-42
In Commercial Distribution

  • 00840277131980 ()
4576-42

  • Surgical drill guide, reusable
Beaule Femoral Head Sizer 0mm
INNOMED, INC.
4576-40
In Commercial Distribution

  • 00840277131973 ()
4576-40

  • Surgical drill guide, reusable
Beaule Femoral Head Sizer Set
INNOMED, INC.
4576
In Commercial Distribution

  • 00840277131966 ()
4576

  • Surgical drill guide, reusable
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