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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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Silex Sacroiliac Joint Fusion System - M697X07900601

12.5mm IMPLANT DRIVER ASSY, CANNULATED
Xtant Medical Holdings, Inc.
X079-0060
In Commercial Distribution

  • M697X07900600 ()
  • M697X07900601 ()

  • Outer Diameter: 12.5 Millimeter


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit

Silex Sacroiliac Joint Fusion System - M697X07900331

7mm ADJUSTMENT IMPLANT DRIVER, CANNULATED
Xtant Medical Holdings, Inc.
X079-0033
In Commercial Distribution

  • M697X07900330 ()
  • M697X07900331 ()

  • Outer Diameter: 7 Millimeter


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit

Silex Sacroiliac Joint Fusion System - M697X07900301

7mm IMPLANT DRIVER ASSY, CANNULATED
Xtant Medical Holdings, Inc.
X079-0030
In Commercial Distribution

  • M697X07900300 ()
  • M697X07900301 ()

  • Outer Diameter: 7 Millimeter


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit

FixxSure - M711201160

FixxSure Cross Link Hex Driver, SST, Radel
Innovasis, Inc.
20116
In Commercial Distribution

  • M711201160 ()


  • Orthopaedic implant driver

Neobiotech Implant System - 08809815659043

Ø1.7, L:10.0mm
Neobiotech. co., ltd
TXDC1710
In Commercial Distribution

  • 08809815659043 ()


  • Surgical screwdriver, reusable

Neobiotech Implant System - 08809815659036

Ø1.7, L:15.0mm
Neobiotech. co., ltd
TXDC1715
In Commercial Distribution

  • 08809815659036 ()


  • Surgical screwdriver, reusable

Neobiotech Implant System - 08809815659029

Ø1.7, L:20.0mm
Neobiotech. co., ltd
TXDC1720
In Commercial Distribution

  • 08809815659029 ()


  • Surgical screwdriver, reusable

Neobiotech Implant System - 08809815659012

Ø3.5, L:20.0mm
Neobiotech. co., ltd
EZPHD3520
In Commercial Distribution

  • 08809815659012 ()


  • Surgical screwdriver, reusable

Neobiotech Implant System - 08809815659005

2.4Hex, N
Neobiotech. co., ltd
EBFDH24
In Commercial Distribution

  • 08809815659005 ()


  • Surgical screwdriver, reusable

Neobiotech Implant System - 08809815658992

2.7Hex, R
Neobiotech. co., ltd
EBFDH27
In Commercial Distribution

  • 08809815658992 ()


  • Surgical screwdriver, reusable

Neobiotech Implant System - 08809815658985

3.4Hex, W(B)
Neobiotech. co., ltd
EBFDH34
In Commercial Distribution

  • 08809815658985 ()


  • Surgical screwdriver, reusable

Neobiotech Implant System - 08809815658961

Ø4.0
Neobiotech. co., ltd
CMCCD22
In Commercial Distribution

  • 08809815658961 ()


  • Surgical screwdriver, reusable

Neobiotech Implant System - 08809815658671

Ø3.5, L:2.0mm
Neobiotech. co., ltd
EZPHD3502
In Commercial Distribution

  • 08809815658671 ()


  • Surgical screwdriver, reusable

Neobiotech Implant System - 08809815658664

Ø3.5, L:12.0mm
Neobiotech. co., ltd
EZPHD3512
In Commercial Distribution

  • 08809815658664 ()


  • Surgical screwdriver, reusable

Neobiotech Implant System - 08809815658657

3.1 Octa, Short, Contra Angle
Neobiotech. co., ltd
ITFDO31S
In Commercial Distribution

  • 08809815658657 ()


  • Surgical screwdriver, reusable

Neobiotech Implant System - 08809815658640

3.1 Octa, Long, Contra Angle
Neobiotech. co., ltd
ITFDO31L
In Commercial Distribution

  • 08809815658640 ()


  • Surgical screwdriver, reusable

Neobiotech Implant System - 08809815658619

2.5Hex, Contra Angle, Narrow
Neobiotech. co., ltd
ISFD05C
In Commercial Distribution

  • 08809815658619 ()


  • Surgical screwdriver, reusable

Neobiotech Implant System - 08809815658602

2.1 Hex, Contra Angle, Long
Neobiotech. co., ltd
ISFDSNCL
In Commercial Distribution

  • 08809815658602 ()


  • Surgical screwdriver, reusable

Neobiotech Implant System - 08809815658596

2.5Hex, Contra Angle, Long
Neobiotech. co., ltd
ISFD05CL
In Commercial Distribution

  • 08809815658596 ()


  • Surgical screwdriver, reusable

Neobiotech Implant System - 08809815658527

Contra Angle, Narrow
Neobiotech. co., ltd
NGISFDCAN
In Commercial Distribution

  • 08809815658527 ()


  • Surgical screwdriver, reusable

Neobiotech Implant System - 08809815658510

Contra Angle, Regular, Wide
Neobiotech. co., ltd
NGISFDCA
In Commercial Distribution

  • 08809815658510 ()


  • Surgical screwdriver, reusable

Neobiotech Implant System - 08809815658459

Contra Angle Regular Wide
Neobiotech. co., ltd
NGISFDCARW
In Commercial Distribution

  • 08809815658459 ()


  • Surgical screwdriver, reusable

Neobiotech Implant System - 08809815658442

Contra Angle, Narrow
Neobiotech. co., ltd
NGISFDCANA
In Commercial Distribution

  • 08809815658442 ()


  • Surgical screwdriver, reusable

Neobiotech Implant System - 08809815658435

Contra Angle, S-Narrow
Neobiotech. co., ltd
NGISFDCASN
In Commercial Distribution

  • 08809815658435 ()


  • Surgical screwdriver, reusable

Implant Remover - 08809854027506

Ø6.4~Ø7.3/Long
Megagen Implant Co. Ltd
IRL6080
In Commercial Distribution

  • 08809854027506 ()
IRL6080

  • Surgical screwdriver, reusable

Implant Remover - 08809854027490

Ø6.4~Ø7.3/Short
Megagen Implant Co. Ltd
IRS6080
In Commercial Distribution

  • 08809854027490 ()
IRS6080

  • Surgical screwdriver, reusable

Screw Remover Guide - 08809854027179

Internal/Long
Megagen Implant Co. Ltd
SRGL22
In Commercial Distribution

  • 08809854027179 ()
SRGL22

  • Surgical screwdriver, reusable

Screw Remover Guide - 08809854027162

Internal/Short
Megagen Implant Co. Ltd
SRGS22
In Commercial Distribution

  • 08809854027162 ()
SRGS22

  • Surgical screwdriver, reusable

Screw Remover Guide - 08809854027155

Internal/Long
Megagen Implant Co. Ltd
SRGL10
In Commercial Distribution

  • 08809854027155 ()
SRGL10

  • Surgical screwdriver, reusable

Screw Remover Guide - 08809854027148

Internal/Short
Megagen Implant Co. Ltd
SRGS10
In Commercial Distribution

  • 08809854027148 ()
SRGS10

  • Surgical screwdriver, reusable

Screw Tapping Driver - 08809854027131

Ø0.9/Long
Megagen Implant Co. Ltd
STDL20
In Commercial Distribution

  • 08809854027131 ()
STDL20

  • Surgical screwdriver, reusable

Screw Tapping Driver - 08809854027124

Ø0.9/Short
Megagen Implant Co. Ltd
STDS20
In Commercial Distribution

  • 08809854027124 ()
STDS20

  • Surgical screwdriver, reusable

Screw Tapping Driver - 08809854027117

Ø0.7/Long
Megagen Implant Co. Ltd
STDL18
In Commercial Distribution

  • 08809854027117 ()
STDL18

  • Surgical screwdriver, reusable

Screw Tapping Driver - 08809854027100

Ø0.7/Short
Megagen Implant Co. Ltd
STDS18
In Commercial Distribution

  • 08809854027100 ()
STDS18

  • Surgical screwdriver, reusable

Screw Tapping Driver - 08809854027094

Ø0.5/Long
Megagen Implant Co. Ltd
STDL16
In Commercial Distribution

  • 08809854027094 ()
STDL16

  • Surgical screwdriver, reusable

Screw Tapping Driver - 08809854027087

Ø0.5/Short
Megagen Implant Co. Ltd
STDS16
In Commercial Distribution

  • 08809854027087 ()
STDS16

  • Surgical screwdriver, reusable

Screw Tapping Driver - 08809854027070

Ø0.3/Long
Megagen Implant Co. Ltd
STDL14
In Commercial Distribution

  • 08809854027070 ()
STDL14

  • Surgical screwdriver, reusable

Screw Tapping Driver - 08809854027063

Ø0.3/Short
Megagen Implant Co. Ltd
STDS14
In Commercial Distribution

  • 08809854027063 ()
STDS14

  • Surgical screwdriver, reusable

Abutemnt Remover - 08809854026936

M2.0/Long
Megagen Implant Co. Ltd
ARL20
In Commercial Distribution

  • 08809854026936 ()
ARL20

  • Surgical screwdriver, reusable

Abutemnt Remover - 08809854026929

M2.0/Short
Megagen Implant Co. Ltd
ARS20
In Commercial Distribution

  • 08809854026929 ()
ARS20

  • Surgical screwdriver, reusable

Abutemnt Remover - 08809854026912

M1.8/Long
Megagen Implant Co. Ltd
ARL18
In Commercial Distribution

  • 08809854026912 ()
ARL18

  • Surgical screwdriver, reusable

Abutemnt Remover - 08809854026905

M1.8/Short
Megagen Implant Co. Ltd
ARS18
In Commercial Distribution

  • 08809854026905 ()
ARS18

  • Surgical screwdriver, reusable

Implant Tapping Remover - 08809854026899

Ø2.5 / Long
Megagen Implant Co. Ltd
ITR25L
In Commercial Distribution

  • 08809854026899 ()
ITR25L

  • Surgical screwdriver, reusable

Implant Tapping Remover - 08809854026882

Ø2.5 / Short
Megagen Implant Co. Ltd
ITR25S
In Commercial Distribution

  • 08809854026882 ()
ITR25S

  • Surgical screwdriver, reusable

Implant Tapping Remover - 08809854026875

Ø2.5 / Ultra Short
Megagen Implant Co. Ltd
ITR25U
In Commercial Distribution

  • 08809854026875 ()
ITR25U

  • Surgical screwdriver, reusable

Implant Tapping Remover - 08809854026868

Ø3.5 / Long
Megagen Implant Co. Ltd
ITR35L
In Commercial Distribution

  • 08809854026868 ()
ITR35L

  • Surgical screwdriver, reusable

Implant Tapping Remover - 08809854026851

Ø3.5 / Short
Megagen Implant Co. Ltd
ITR35S
In Commercial Distribution

  • 08809854026851 ()
ITR35S

  • Surgical screwdriver, reusable

Implant Tapping Remover - 08809854026844

Ø3.5 / Ultra Short
Megagen Implant Co. Ltd
ITR35U
In Commercial Distribution

  • 08809854026844 ()
ITR35U

  • Surgical screwdriver, reusable

Implant Tapping Remover - 08809854026837

Ø4.5 / Long
Megagen Implant Co. Ltd
ITR45L
In Commercial Distribution

  • 08809854026837 ()
ITR45L

  • Surgical screwdriver, reusable

Implant Tapping Remover - 08809854026820

Ø4.5 / Short
Megagen Implant Co. Ltd
ITR45S
In Commercial Distribution

  • 08809854026820 ()
ITR45S

  • Surgical screwdriver, reusable
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