Arsenal Deformity Spinal Fixation System

GUDID 00840967161198

CoCr1 Straight Rod, 5.5 x 100mm

ALPHATEC SPINE, INC.

Bone-screw internal spinal fixation system, sterile
Primary Device ID00840967161198
NIH Device Record Keyd8f84ee3-3c12-4355-921d-2068b9895482
Commercial Distribution StatusIn Commercial Distribution
Brand NameArsenal Deformity Spinal Fixation System
Version Model Number48017-55-100
Company DUNS602465783
Company NameALPHATEC SPINE, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter5.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840967161198 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840967161198]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-04-27

On-Brand Devices [Arsenal Deformity Spinal Fixation System]

00190376006147Rod Connector, Closed 5.5mm Side-Loading 6.35mm
00190376006130Rod Connector, Closed 5.5mm Side-Loading 5.5
00840967116945ILIAC BOLT, 15 DEGREE, 9.0mm X 130mm
00840967116938ILIAC BOLT, 15 DEGREE, 9.0mm X 125mm
00840967116921ILIAC BOLT, 15 DEGREE, 9.0mm X 120mm
00840967116914ILIAC BOLT, 15 DEGREE, 9.0mm X 115mm
00840967116907ILIAC BOLT, 15 DEGREE, 9.0mm X 110mm
00840967116891ILIAC BOLT, 15 DEGREE, 9.0mm X 105mm
00840967116884ILIAC BOLT, 15 DEGREE, 9.0mm X 100mm
00840967116877ILIAC BOLT, 15 DEGREE, 9.0mm X 95mm
00840967116860ILIAC BOLT, 15 DEGREE, 9.0mm X 90mm
00840967116853Iliac Bolt, 15°, 9.0mm X 90mm
00840967116846ILIAC BOLT, 15 DEGREE, 9.0mm X 80mm
00840967116839Iliac Bolt, 15°, 9.0mm X 80mm
00840967116822ILIAC BOLT, 15 DEGREE, 9.0mm X 70mm
00840967116815Iliac Bolt, 15°, 9.0mm X 70mm
00840967116808ILIAC BOLT, 15 DEGREE, 9.0mm X 60mm
00840967116792Iliac Bolt, 15°, 9.0mm X 60mm
00840967116785Iliac Bolt, 15°, 9.0mm X 55mm
00840967116778ILIAC BOLT, 15 DEGREE, 9.0mm X 45mm
00840967116761Iliac Bolt, 15°, 9.0mm X 45mm
00840967116754Iliac Bolt, 15°, 9.0mm X 40mm
00840967116747Iliac Bolt, 15°, 9.0mm X 35mm
00840967116730ILIAC BOLT, 15 DEGREE, 8.5mm X 130mm
00840967116723Iliac Bolt, 15°, 8.5mm X 130mm
00840967116716Iliac Bolt, 15°, 8.5mm X 125mm
00840967116709Iliac Bolt, 15°, 8.5mm X 120mm
00840967116693Iliac Bolt, 15°, 8.5mm X 115mm
00840967116686Iliac Bolt, 15°, 8.5mm X 110mm
00840967116679Iliac Bolt, 15°, 8.5mm X 105mm
00840967116662ILIAC BOLT, 15 DEGREE, 8.5mm X 95mm
00840967116655Iliac Bolt, 15°, 8.5mm X 95mm
00840967116648Iliac Bolt, 15°, 8.5mm X 90mm
00840967116631Iliac Bolt, 15°, 8.5mm X 85mm
00840967116624Iliac Bolt, 15°, 8.5mm X 80mm
00840967116617Iliac Bolt, 15°, 8.5mm X 75mm
00840967116600Iliac Bolt, 15°, 8.5mm X 70mm
00840967116594Iliac Bolt, 15°, 8.5mm X 65mm
00840967116587ILIAC BOLT, 15 DEGREE, 8.5mm X 55mm
00840967116570ILIAC BOLT, 15 DEGREE, 8.5mm X 50mm
00840967116563ILIAC BOLT, 15 DEGREE, 8.5mm X 45mm
00840967116556ILIAC BOLT, 15 DEGREE, 8.5mm X 40mm
00840967116549ILIAC BOLT, 15 DEGREE, 8.5mm X 35mm
00840967116532ILIAC BOLT, 15 DEGREE, 8.5mm X 30mm
00840967116525ILIAC BOLT, 15 DEGREE, 8.0mm X 130mm
00840967116518ILIAC BOLT, 15 DEGREE, 8.0mm X 125mm
00840967116501ILIAC BOLT, 15 DEGREE, 8.0mm X 120mm
00840967116495ILIAC BOLT, 15 DEGREE, 8.0mm X 115mm
00840967116488ILIAC BOLT, 15 DEGREE, 8.0mm X 110mm
00840967116471ILIAC BOLT, 15 DEGREE, 8.0mm X 105mm
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