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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90° Infant Offset Plate, 4-Hole, 6mm Offset
ORTHOPEDIATRICS CORP.
00-3001-1964
In Commercial Distribution

  • 00840194472692 ()
00-3001-1964

  • Femoral neck fixation plate/sleeve
90° Infant Offset Plate, 3-Hole, 6mm Offset
ORTHOPEDIATRICS CORP.
00-3001-1963
In Commercial Distribution

  • 00840194472685 ()
00-3001-1963

  • Femoral neck fixation plate/sleeve
90° Infant Offset Plate, 2-Hole, 6mm Offset
ORTHOPEDIATRICS CORP.
00-3001-1962
In Commercial Distribution

  • 00840194472678 ()
00-3001-1962

  • Femoral neck fixation plate/sleeve
13mm Opening Reamer
ORTHOPEDIATRICS CORP.
01-1501-0093-S
In Commercial Distribution

  • 00840194472616 ()
01-1501-0093-S

  • Medullary canal orthopaedic reamer shaft
12mm Opening Reamer
ORTHOPEDIATRICS CORP.
01-1501-0092-S
In Commercial Distribution

  • 00840194472609 ()
01-1501-0092-S

  • Medullary canal orthopaedic reamer shaft
11mm Opening Reamer
ORTHOPEDIATRICS CORP.
01-1501-0091-S
In Commercial Distribution

  • 00840194472593 ()
01-1501-0091-S

  • Medullary canal orthopaedic reamer shaft
10mm Opening Reamer
ORTHOPEDIATRICS CORP.
01-1501-0090-S
In Commercial Distribution

  • 00840194472586 ()
01-1501-0090-S

  • Medullary canal orthopaedic reamer shaft
PNP Screw Easy Off
ORTHOPEDIATRICS CORP.
01-1501-0076-S
In Commercial Distribution

  • 00840194472401 ()
01-1501-0076-S

  • Surgical screwdriver, single-use
4.5/5.0 Pedicle Screw Driver, Navigation
ORTHOPEDIATRICS CORP.
01-1800-6044
In Commercial Distribution

  • 00840194466882 ()
01-1800-6044

  • Surgical screwdriver, reusable
Driver, Cannulated 5.0mm Hex
ORTHOPEDIATRICS CORP.
01-9200-0150
In Commercial Distribution

  • 00840194465298 ()
01-9200-0150

  • Surgical screwdriver, reusable
Driver, Solid 4.5mm Hex
ORTHOPEDIATRICS CORP.
01-9200-0045
In Commercial Distribution

  • 00840194465267 ()
01-9200-0045

  • Surgical screwdriver, reusable
Driver, Solid 4.0mm Hex
ORTHOPEDIATRICS CORP.
01-9200-0040
In Commercial Distribution

  • 00840194465243 ()
01-9200-0040

  • Surgical screwdriver, reusable
Driver, Solid 3.5mm Hex
ORTHOPEDIATRICS CORP.
01-9200-0035
In Commercial Distribution

  • 00840194465229 ()
01-9200-0035

  • Surgical screwdriver, reusable
Driver, Cannulated 3.0mm Hex
ORTHOPEDIATRICS CORP.
01-9200-0130
In Commercial Distribution

  • 00840194465212 ()
01-9200-0130

  • Surgical screwdriver, reusable
Driver, Solid 2.5mm Hex
ORTHOPEDIATRICS CORP.
01-9200-0025
In Commercial Distribution

  • 00840194465182 ()
01-9200-0025

  • Surgical screwdriver, reusable
Driver, Cannulated T15
ORTHOPEDIATRICS CORP.
01-9200-0115
In Commercial Distribution

  • 00840194465151 ()
01-9200-0115

  • Surgical screwdriver, reusable
Driver, Solid T10
ORTHOPEDIATRICS CORP.
01-9200-0010
In Commercial Distribution

  • 00840194465137 ()
01-9200-0010

  • Surgical screwdriver, reusable
5.5/6.0 Cannulated Pedicle Screw Driver Navigation
ORTHOPEDIATRICS CORP.
01-1800-6042
In Commercial Distribution

  • 00840194462778 ()
01-1800-6042

  • Surgical screwdriver, reusable
PNP Retaining End Cap Driver, ZH QC
ORTHOPEDIATRICS CORP.
01-1510-0047
In Commercial Distribution

  • 00840194446112 ()
01-1510-0047

  • Surgical screwdriver, reusable
Ball Hex Driver, ZH QC
ORTHOPEDIATRICS CORP.
01-1510-0045
In Commercial Distribution

  • 00840194446099 ()
01-1510-0045

  • Surgical screwdriver, reusable
Tapered Screw Driver, 4.0 Hex, Long, ZH QC
ORTHOPEDIATRICS CORP.
01-1510-0044
In Commercial Distribution

  • 00840194445979 ()
01-1510-0044

  • Surgical screwdriver, reusable
5.5/6.0 Closed Pedicle screw driver, T20, Zimmer Hudson
ORTHOPEDIATRICS CORP.
01-1301-6043
In Commercial Distribution

  • 00840194445849 ()
01-1301-6043

  • Surgical screwdriver, reusable
5.5/6.0 Closed Pedicle screw driver, T20, Square
ORTHOPEDIATRICS CORP.
01-1301-6042
In Commercial Distribution

  • 00840194445832 ()
01-1301-6042

  • Surgical screwdriver, reusable
5.5/6.0 Closed Cannulated Pedicle Screw Driver, Zimmer Hudson
ORTHOPEDIATRICS CORP.
01-1301-6040
In Commercial Distribution

  • 00840194445818 ()
01-1301-6040

  • Surgical screwdriver, reusable
4.5/5.0 Power Pedicle Screw Driver, 140MM
ORTHOPEDIATRICS CORP.
01-1600-9010
In Commercial Distribution

  • 00840194444927 ()
01-1600-9010

  • Surgical screwdriver, reusable
5.5/6.0 Power CANNULATED Pedicle Screw Driver, 140MM
ORTHOPEDIATRICS CORP.
01-1301-9010
In Commercial Distribution

  • 00840194444903 ()
01-1301-9010

  • Surgical screwdriver, reusable
5.5/6.0 Power Pedicle Screw Driver, 140MM
ORTHOPEDIATRICS CORP.
01-1300-9010
In Commercial Distribution

  • 00840194444880 ()
01-1300-9010

  • Surgical screwdriver, reusable
Internal Capture Release Driver
ORTHOPEDIATRICS CORP.
01-1510-0029
In Commercial Distribution

  • 00840194429047 ()
01-1510-0029

  • Surgical screwdriver, reusable
Internal Thread Capture, Long
ORTHOPEDIATRICS CORP.
01-1510-0028
In Commercial Distribution

  • 00840194429030 ()
01-1510-0028

  • Surgical screwdriver, reusable
Internal Thread Capture, Short
ORTHOPEDIATRICS CORP.
01-1510-0027
In Commercial Distribution

  • 00840194429023 ()
01-1510-0027

  • Surgical screwdriver, reusable
Screwdriver, 4mm Hex, Long
ORTHOPEDIATRICS CORP.
01-1510-0026
In Commercial Distribution

  • 00840194429016 ()
01-1510-0026

  • Surgical screwdriver, reusable
SLAP HAMMER
TITAN SPINE, LLC
7200-1065
Not in Commercial Distribution

  • M682720010650 ()

  • Length: 10 Inch
7200-1065

  • Surgical mallet
Tool used to thread and unscrew the top of the countersink body for easy disassembly.
ABANZA TECNOMED SL.
21
In Commercial Distribution

  • 08437019739331 ()
  • 28437019739335 ()


  • Surgical screwdriver, reusable
Screwdriver IO adaptor. L21mm
TALLADIUM ESPAÑA SL
43.621.410.01-2
In Commercial Distribution

  • 08436568735733 ()


  • Surgical screwdriver, reusable
DAS Multi-Unit insertion tool
TALLADIUM ESPAÑA SL
49.409.000.01-2
In Commercial Distribution

  • 08436568733937 ()


  • Surgical torque wrench adaptor
DAS Multi-Unit Screwdriver. L21mm
TALLADIUM ESPAÑA SL
43.321.316.01-2
In Commercial Distribution

  • 08436568733722 ()


  • Surgical screwdriver, reusable
Atlantis Angulated Screw Access Screwdriver L24mm, 30
TALLADIUM ESPAÑA SL
36031
In Commercial Distribution

  • 08436568732527 ()


  • Surgical screwdriver, reusable
40 Deg Fixed Angle Driver
TITAN SPINE, LLC
2300-1313
Not in Commercial Distribution

  • M682230013130 ()
2300-1313

  • Orthopaedic inorganic implant inserter/extractor, reusable
RFS™ Driver Insert 3.5mm
Bioretec Oy
RFS-DI35
Not in Commercial Distribution

  • E302RFSDI359 ()
RFS-DI35

  • Surgical screwdriver, reusable
RFS™ Driver Insert 2.5mm
Bioretec Oy
RFS-DI25
Not in Commercial Distribution

  • E302RFSDI259 ()
RFS-DI25

  • Surgical screwdriver, reusable
RFS Cannulated Hex Shaft 3.5
Bioretec Oy
RFS-CHS35
Not in Commercial Distribution

  • E302RFSCHS359 ()
RFS-CHS35

  • Surgical screwdriver, reusable
RFS Cannulated Hex Shaft 2.5
Bioretec Oy
RFS-CHS25
Not in Commercial Distribution

  • E302RFSCHS259 ()
RFS-CHS25

  • Surgical screwdriver, reusable
RFS Cannulated Handle Large
Bioretec Oy
RFS-CHDL
Not in Commercial Distribution

  • E302RFSCHDL9 ()
RFS-CHDL

  • Surgical screwdriver, reusable
RFS Cannulated Direct driver 4.5
Bioretec Oy
RFS-CDDR45
Not in Commercial Distribution

  • E302RFSCDDR459 ()
RFS-CDDR45

  • Surgical screwdriver, reusable
RFS Cannulated Direct driver 3.5
Bioretec Oy
RFS-CDDR35
Not in Commercial Distribution

  • E302RFSCDDR359 ()
RFS-CDDR35

  • Surgical screwdriver, reusable
TorqLoc Large handle, cannulated, quick coupling
Bioretec Oy
OP-ISC-9013
Not in Commercial Distribution

  • E302OPISC90139 ()
OP-ISC-9013

  • Surgical screwdriver, reusable
TorqLoc Torx shaft for 4/5/6 mm interference screw with quick coupling
Bioretec Oy
OP-II-9032
Not in Commercial Distribution

  • E302OPII90329 ()
OP-II-9032

  • Surgical screwdriver, reusable
TorqLoc Torx driver for 7/8/9/10 mm interference screw
Bioretec Oy
OP-II-9031
Not in Commercial Distribution

  • E302OPII90319 ()
OP-II-9031

  • Surgical screwdriver, reusable
HEX shaft, for 4.0/4.5 mm cannulated screws
Bioretec Oy
B-ISC-9033
In Commercial Distribution

  • E302BISC90339 ()
B-ISC-9033

  • Surgical screwdriver, reusable
HEX shaft, for 3.5 mm cannulated screws
Bioretec Oy
B-ISC-9032
In Commercial Distribution

  • E302BISC90329 ()
B-ISC-9032

  • Surgical screwdriver, reusable
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