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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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Biomet® Knee System - 00880304009738

No Description
Biomet Orthopedics, LLC
141205
In Commercial Distribution

  • 00880304009738 ()
141205

  • Uncoated knee tibia prosthesis, metallic

N/A - 00681490993616

DRIVER 9098061 HEX STANDARD
MEDTRONIC SOFAMOR DANEK, INC.
9098061
In Commercial Distribution

  • 00681490993616 ()


  • Surgical screwdriver, reusable

BIO-MODULAR SHOULDER SYSTEM - 00880304009639

No Description
Biomet Orthopedics, LLC
11-113800
In Commercial Distribution

  • 00880304009639 ()

  • 7 MM 190 MM
11-113800

  • Coated shoulder humeral stem prosthesis

N/A - 00681490993548

DRILL BIT 9098040 FACET SCREW
MEDTRONIC SOFAMOR DANEK, INC.
9098040
In Commercial Distribution

  • 00681490993548 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable

Medtronic Reusable Instruments - 00681490993258

2MM DOWNBIT PITUITARY W/TEETH
MEDTRONIC SOFAMOR DANEK, INC.
X9560569
In Commercial Distribution

  • 00681490993258 ()


  • Orthopaedic joint/limb rongeur

Medtronic Reusable Instruments - 00681490993241

MICROPITUITARY X9560567 2MM UPBTNG TEETH
MEDTRONIC SOFAMOR DANEK, INC.
X9560567
In Commercial Distribution

  • 00681490993241 ()


  • Orthopaedic joint/limb rongeur

Medtronic Reusable Instruments - 00681490993210

2MM UPBITING PITUITARY W/TEETH
MEDTRONIC SOFAMOR DANEK, INC.
X9560564
In Commercial Distribution

  • 00681490993210 ()


  • Orthopaedic joint/limb rongeur

RING-LOC(R) ACETABULAR TRIAL - 00880304009523

No Description
Biomet Orthopedics, LLC
433756
In Commercial Distribution

  • 00880304009523 ()
433756

  • Acetabulum prosthesis trial, prefabricated, reusable

Medtronic Reusable Instruments - 00681490993180

2MM BAYONET KERRISON, 90
MEDTRONIC SOFAMOR DANEK, INC.
X9560603
In Commercial Distribution

  • 00681490993180 ()


  • Bone curette, reusable

RING-LOC(R) ACETABULAR TRIAL - 00880304009509

No Description
Biomet Orthopedics, LLC
433764
In Commercial Distribution

  • 00880304009509 ()
433764

  • Acetabulum prosthesis trial, prefabricated, reusable

Medtronic Reusable Instruments - 00681490993166

1MM BAYONET KERRISON, 90
MEDTRONIC SOFAMOR DANEK, INC.
X9560601
In Commercial Distribution

  • 00681490993166 ()


  • Bone curette, reusable

TAPERLOC HIP SYSTEM - 00880304009165

No Description
Biomet Orthopedics, LLC
11-103207
In Commercial Distribution

  • 00880304009165 ()

  • 13.5 SIZE 147 MM TYPE1 TAPER
11-103207

  • Coated hip femur prosthesis, modular

MODULAR HEAD - 00880304009127

No Description
Biomet Orthopedics, LLC
31-380355
In Commercial Distribution

  • 00880304009127 ()

  • PLUS 10.5MM
31-380355

  • Femoral head prosthesis trial

MAXIM KNEE SYSTEM - 00880304009097

No Description
Biomet Orthopedics, LLC
145112
In Commercial Distribution

  • 00880304009097 ()

  • 65MM
145112

  • Uncoated knee femur prosthesis, metallic

BMP THIN OSTEOTOME - 00880304009066

No Description
Biomet Orthopedics, LLC
430056
In Commercial Distribution

  • 00880304009066 ()
430056

  • Orthopaedic osteotome blade, reusable

DISCOVERY ELBOW SYSTEM - 00880304009059

No Description
Biomet Orthopedics, LLC
114813
In Commercial Distribution

  • 00880304009059 ()

  • 3 MM 75MM LENGTH
114813

  • Metal-backed elbow ulna prosthesis

MALLORY/HEAD CALCAR HIP SYSTEM - 00880304009042

No Description
Biomet Orthopedics, LLC
11-135162
In Commercial Distribution

  • 00880304009042 ()

  • 13 SIZE 165 MM
11-135162

  • Acetabular shell

REACH MODULAR HIP SYSTEM - 00880304009035

No Description
Biomet Orthopedics, LLC
21-108395
In Commercial Distribution

  • 00880304009035 ()

  • 3 SIZE TYPE I TAPER
21-108395

  • Coated hip femur prosthesis, modular

TITANIUM INTERFERENCE SCREW - 00880304009028

No Description
Biomet Sports Medicine, LLC
909694
In Commercial Distribution

  • 00880304009028 ()

  • 11 MM 20 MM ROUND HEAD
909694

  • Ligament bone anchor

ALLIANCE FEMORAL OSTEOTOMY GUIDES - 00880304008991

No Description
Biomet Orthopedics, LLC
31-473625
In Commercial Distribution

  • 00880304008991 ()
31-473625

  • Surgical drill guide, reusable

BIOMET KNEE - 00880304008953

No Description
Biomet Orthopedics, LLC
32-341616
In Commercial Distribution

  • 00880304008953 ()

  • 16MM X 80MM
32-341616

  • Knee tibia prosthesis trial, reusable

BIOMET KNEE - 00880304008946

No Description
Biomet Orthopedics, LLC
32-341614
In Commercial Distribution

  • 00880304008946 ()

  • 14MM X 80MM
32-341614

  • Knee femur prosthesis trial, reusable

MAXIM KNEE SYSTEM - 00880304008779

No Description
Biomet Orthopedics, LLC
145310
In Commercial Distribution

  • 00880304008779 ()

  • 6MM 55MM
145310

  • Knee arthroplasty wedge

INTEGRATED SHOULDER SYSTEM - 00880304008755

No Description
Biomet Orthopedics, LLC
490309125
In Commercial Distribution

  • 00880304008755 ()

  • 9.5MM Ø 125MM LENGTH
490309125

  • Coated shoulder humeral stem prosthesis

RingLoc® Hip System - 00880304008700

No Description
Biomet Orthopedics, LLC
103533
In Commercial Distribution

  • 00880304008700 ()

  • 6.5 mm x 30 mm
103533

  • Orthopaedic bone screw, non-bioabsorbable, sterile

RingLoc® Hip System - 00880304008694

No Description
Biomet Orthopedics, LLC
103532
In Commercial Distribution

  • 00880304008694 ()

  • 6.5 mm x 25 mm
103532

  • Orthopaedic bone screw, non-bioabsorbable, sterile

SUTURE ANCHOR INSTRUMENTATION - 00880304008656

No Description
Biomet Orthopedics, LLC
905561
In Commercial Distribution

  • 00880304008656 ()
905561

  • Surgical drill guide obturator

LACTOSCREW INSTRUMENTS - 00880304008601

No Description
Biomet Orthopedics, LLC
905585
In Commercial Distribution

  • 00880304008601 ()

  • 3.5 MM
905585

  • Fluted surgical drill bit, single-use, non-sterile

SUTURE ANCHOR INSTRUMENTATION - 00880304008571

No Description
Biomet Orthopedics, LLC
905560
In Commercial Distribution

  • 00880304008571 ()
905560

  • Surgical drill guide, reusable

MAXIM KNEE SYSTEM - 00880304008540

No Description
Biomet Orthopedics, LLC
140074
In Commercial Distribution

  • 00880304008540 ()

  • 75MM
140074

  • Coated knee femur prosthesis
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