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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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Apache - M719GP638L090

Large Cervical Trial with Handle, No Stop
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GP638L090 ()

  • Length: 9 Millimeter
GP638-L09

  • Vertebral body prosthesis, non-sterile

Apache - M719GP638L080

Large Cervical Trial with Handle, No Stop
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GP638L080 ()

  • Length: 8 Millimeter
GP638-L08

  • Vertebral body prosthesis, non-sterile

Apache - M719GP638L070

Large Cervical Trial with Handle, No Stop
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GP638L070 ()

  • Length: 7 Millimeter
GP638-L07

  • Vertebral body prosthesis, non-sterile

Apache - M719GP638L060

Large Cervical Trial with Handle, No Stop
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GP638L060 ()

  • Length: 6 Millimeter
GP638-L06

  • Vertebral body prosthesis, non-sterile

Apache - M719GP638L050

Large Cervical Trial with Handle, No Stop
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GP638L050 ()

  • Length: 5 Millimeter
GP638-L05

  • Vertebral body prosthesis, non-sterile

Sacroiliac Joint Fusion System - M719PM20210

Posterior SI Allograft, Dual, 20mm with Putty
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719PM20210 ()
PM2021

  • Bone graft syringe, reusable

MAXUM - M737M420R1

IMPLANT ASSEMBLY WITH IPC, SPLIT COIL, RIGHT
Ototronix, LLC
M420R
In Commercial Distribution

  • M737M420R1 ()


  • Partially-implantable middle ear implant system

MAXUM - M737M420L1

IMPLANT ASSEMBLY WITH IPC, SPLIT COIL, LEFT
Ototronix, LLC
M420L
In Commercial Distribution

  • M737M420L1 ()


  • Partially-implantable middle ear implant system

TiLock - M719GL201TIB0

T-Ratchet Handle with Impact Cap (Black Handle)
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GL201TIB0 ()
GL201TI-B

  • Bone-screw internal spinal fixation system, non-sterile

NA - EATO430125SINGLE9

K-wire with trocar point, ø1.2, L 150
aap Implantate AG
430125SINGLE
Not in Commercial Distribution

  • EATO430125SINGLE9 ()


  • Orthopaedic bone pin, non-bioabsorbable
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