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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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Maxim Knee System - 00880304002241

No Description
Biomet Orthopedics, LLC
11-146550
In Commercial Distribution

  • 00880304002241 ()

  • 10MM 71/75MM
11-146550

  • Tibial insert

RINGLOC BI-POLAR HIP SYSTEM - 00880304002227

No Description
Biomet Orthopedics, LLC
11-165222
In Commercial Distribution

  • 00880304002227 ()

  • 49MM OUTER Ø 28MM INNER Ø
11-165222

  • Bipolar femoral head outer component, hemiarthroplasty

PREMIER® Anterior Cervical Plate System - 00681490482400

PLATE 6860185 85 MM ANT CERV
MEDTRONIC SOFAMOR DANEK, INC.
6860185
In Commercial Distribution

  • 00681490482400 ()

  • Width: 85.0 Millimeter


  • Spinal fixation plate, non-bioabsorbable

AGC TRADITION P.S. PROVISIONAL - 00880304002166

No Description
Biomet Orthopedics, LLC
32-470301
In Commercial Distribution

  • 00880304002166 ()
32-470301

  • Knee tibia prosthesis trial, reusable

PREMIER® Anterior Cervical Plate System - 00681490482387

PLATE 6860180 80 MM ANT CERV
MEDTRONIC SOFAMOR DANEK, INC.
6860180
Not in Commercial Distribution

  • 00681490482387 ()

  • Width: 80.0 Millimeter


  • Spinal fixation plate, non-bioabsorbable

PREMIER EZ-CLEAN ACETABULAR REAMER - 00880304002128

No Description
Biomet Orthopedics, LLC
29-476140
In Commercial Distribution

  • 00880304002128 ()
29-476140

  • Acetabular orthopaedic reamer

PREMIER EZ-CLEAN ACETABULAR REAMER - 00880304002098

No Description
Biomet Orthopedics, LLC
29-476154
In Commercial Distribution

  • 00880304002098 ()
29-476154

  • Acetabular orthopaedic reamer

PREMIER EZ-CLEAN ACETABULAR REAMER - 00880304002074

No Description
Biomet Orthopedics, LLC
29-476148
In Commercial Distribution

  • 00880304002074 ()
29-476148

  • Acetabular orthopaedic reamer

PREMIER EZ-CLEAN - 00880304002067

No Description
Biomet Orthopedics, LLC
29-476158
In Commercial Distribution

  • 00880304002067 ()

  • 58 MM
29-476158

  • Acetabular orthopaedic reamer

PREMIER EZ-CLEAN ACETABULAR REAMER - 00880304002050

No Description
Biomet Orthopedics, LLC
29-476146
In Commercial Distribution

  • 00880304002050 ()
29-476146

  • Acetabular orthopaedic reamer

RING-LOC(R) ACETABULAR TRIAL - 00880304002043

No Description
Biomet Orthopedics, LLC
433748
In Commercial Distribution

  • 00880304002043 ()
433748

  • Acetabulum prosthesis trial, prefabricated, reusable

RING-LOC(R) ACETABULAR TRIAL - 00880304002036

No Description
Biomet Orthopedics, LLC
433754
In Commercial Distribution

  • 00880304002036 ()

  • 54 MM
433754

  • Acetabulum prosthesis trial, prefabricated, reusable

RING-LOC(R) ACETABULAR TRIAL - 00880304002029

No Description
Biomet Orthopedics, LLC
433768
In Commercial Distribution

  • 00880304002029 ()

  • 68 MM
433768

  • Acetabulum prosthesis trial, prefabricated, reusable

Gentle Threads - 00880304002012

No Description
Biomet Orthopedics, LLC
905601
In Commercial Distribution

  • 00880304002012 ()

  • 7 MM 25 MM FULL THREAD
905601

  • Bioabsorbable orthopaedic bone screw

BIO-MODULAR SHOULDER SYSTEM - 00880304001992

No Description
Biomet Orthopedics, LLC
113766
In Commercial Distribution

  • 00880304001992 ()

  • 44MM HEAD Ø 22MM HEIGHT
113766

  • Stem-fixed metallic humeral head prosthesis

RingLoc® Hip System - 00880304001961

No Description
Biomet Orthopedics, LLC
103531
In Commercial Distribution

  • 00880304001961 ()

  • 6.5 mm x 20 mm
103531

  • Orthopaedic bone screw, non-bioabsorbable, sterile

MALLORY/HEAD CALCAR HIP SYSTEM - 00880304001954

No Description
Biomet Orthopedics, LLC
11-104970
In Commercial Distribution

  • 00880304001954 ()

  • 15 SIZE 220 MM TYPE1 TAPER
11-104970

  • Coated femoral stem prosthesis, modular

ANSWER HIP SYSTEM - 00880304001947

No Description
Biomet Orthopedics, LLC
162603
In Commercial Distribution

  • 00880304001947 ()

  • 13 SIZE 145 MM TYPE1 TAPER
162603

  • Uncoated femoral stem prosthesis, one-piece

RINGLOC BI-POLAR HIP SYSTEM - 00880304001930

No Description
Biomet Orthopedics, LLC
11-165228
In Commercial Distribution

  • 00880304001930 ()

  • 52MM OUTER Ø 28MM INNER Ø
11-165228

  • Bipolar femoral head outer component, hemiarthroplasty

RINGLOC BI-POLAR HIP SYSTEM - 00880304001923

No Description
Biomet Orthopedics, LLC
11-165206
In Commercial Distribution

  • 00880304001923 ()

  • 41MM OUTER Ø 28MM INNER Ø
11-165206

  • Bipolar femoral head outer component, hemiarthroplasty

BIOMET KNEE SYSTEM - 00880304001862

No Description
Biomet Orthopedics, LLC
141515
In Commercial Distribution

  • 00880304001862 ()

  • 79 MM
141515

  • Uncoated knee tibia prosthesis, metallic

ULTRA-DRIVE TOOL - 00880304001855

No Description
Biomet Orthopedics, LLC
423873
In Commercial Distribution

  • 00880304001855 ()
423873

  • Fluted surgical drill bit, reusable

STAGEONE - 00880304001831

No Description
Biomet Orthopedics, LLC
432160
In Commercial Distribution

  • 00880304001831 ()

  • M/L 60 MM A/P 43 MM
432160

  • Orthopaedic cement spacer mould

STAGEONE - 00880304001824

No Description
Biomet Orthopedics, LLC
433165
In Commercial Distribution

  • 00880304001824 ()

  • M/L 65 MM A/P 39 MM
433165

  • Orthopaedic cement spacer mould

PREMIER® Anterior Cervical Plate System - 00681490482363

PLATE 6860175 75 MM ANT CERV
MEDTRONIC SOFAMOR DANEK, INC.
6860175
In Commercial Distribution

  • 00681490482363 ()

  • Width: 75.0 Millimeter


  • Spinal fixation plate, non-bioabsorbable

Carpal Tunnel Release - 00880304001794

No Description
Biomet Orthopedics, LLC
592027
In Commercial Distribution

  • 00880304001794 ()
592027

  • Instrument tray, reusable

AGC Tradition Knee System - 00880304001787

No Description
Biomet Orthopedics, LLC
151006
In Commercial Distribution

  • 00880304001787 ()

  • 12 MM 63/67 MM
151006

  • Tibial insert

AGC Tradition Knee System - 00880304001770

No Description
Biomet Orthopedics, LLC
151007
In Commercial Distribution

  • 00880304001770 ()

  • 14 MM 63/67 MM
151007

  • Tibial insert

PREMIER® Anterior Cervical Plate System - 00681490482325

PLATE 6860165 65 MM ANTERIOR CERVICAL
MEDTRONIC SOFAMOR DANEK, INC.
6860165
In Commercial Distribution

  • 00681490482325 ()

  • Width: 65.0 Millimeter


  • Spinal fixation plate, non-bioabsorbable

Maxim Knee System - 00880304001756

No Description
Biomet Orthopedics, LLC
11-146536
In Commercial Distribution

  • 00880304001756 ()

  • 16MM 63/67MM
11-146536

  • Tibial insert
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