Reform Ti Modular 39-WT-0420

GUDID 00840019938587

Modular Offset Tulip Assembly, 20mm

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840019938587
NIH Device Record Keybc62735b-c3d3-45e0-a99c-d6ba9e77c7bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameReform Ti Modular
Version Model Number39-WT-0420
Catalog Number39-WT-0420
Company DUNS079398589
Company NamePRECISION 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 Identifiers

Device Issuing AgencyDevice ID
GS100840019938587 [Primary]
GS100840019938587 [Primary]
GS100840019938587 [Primary]
GS100840019938587 [Primary]
GS100840019938587 [Primary]
GS100840019938587 [Primary]
GS100840019938587 [Primary]
GS100840019938587 [Primary]
GS100840019938587 [Primary]
GS100840019938587 [Primary]
GS100840019938587 [Primary]
GS100840019938587 [Primary]
GS100840019938587 [Primary]
GS100840019938587 [Primary]
GS100840019938587 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System
NKBThoracolumbosacral Pedicle Screw System
NKBThoracolumbosacral Pedicle Screw System
NKBThoracolumbosacral Pedicle Screw System
NKBThoracolumbosacral Pedicle Screw System
NKBThoracolumbosacral Pedicle Screw System
NKBThoracolumbosacral Pedicle Screw System
NKBThoracolumbosacral Pedicle Screw System
NKBThoracolumbosacral Pedicle Screw System
NKBThoracolumbosacral Pedicle Screw System
NKBThoracolumbosacral Pedicle Screw System
NKBThoracolumbosacral Pedicle Screw System
NKBThoracolumbosacral Pedicle Screw System
NKBThoracolumbosacral Pedicle Screw System
NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019938587]

Moist Heat or Steam Sterilization


[00840019938587]

Moist Heat or Steam Sterilization


[00840019938587]

Moist Heat or Steam Sterilization


[00840019938587]

Moist Heat or Steam Sterilization


[00840019938587]

Moist Heat or Steam Sterilization


[00840019938587]

Moist Heat or Steam Sterilization


[00840019938587]

Moist Heat or Steam Sterilization


[00840019938587]

Moist Heat or Steam Sterilization


[00840019938587]

Moist Heat or Steam Sterilization


[00840019938587]

Moist Heat or Steam Sterilization


[00840019938587]

Moist Heat or Steam Sterilization


[00840019938587]

Moist Heat or Steam Sterilization


[00840019938587]

Moist Heat or Steam Sterilization


[00840019938587]

Moist Heat or Steam Sterilization


[00840019938587]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-23
Device Publish Date2020-06-15

On-Brand Devices [Reform Ti Modular]

00840019934718Ø9.5 x 110mm Polyaxial Screw, Cannulated
00840019934701Ø9.5 x 100mm Polyaxial Screw, Cannulated
00840019934695Ø9.5 x 90mm Polyaxial Screw, Cannulated
00840019934688Ø9.5 x 80mm Polyaxial Screw, Cannulated
00840019934671Ø9.5 x 70mm Polyaxial Screw, Cannulated
00840019934664Ø9.5 x 60mm Polyaxial Screw, Cannulated
00840019934657Ø9.5 x 55mm Polyaxial Screw, Cannulated
00840019934640Ø9.5 x 50mm Polyaxial Screw, Cannulated
00840019934633Ø9.5 x 45mm Polyaxial Screw, Cannulated
00840019934626Ø9.5 x 40mm Polyaxial Screw, Cannulated
00840019934619Ø8.5 x 120mm Polyaxial Screw, Cannulated
00840019934602Ø8.5 x 110mm Polyaxial Screw, Cannulated
00840019934596Ø8.5 x 100mm Polyaxial Screw, Cannulated
00840019934589Ø8.5 x 90mm Polyaxial Screw, Cannulated
00840019934572Ø8.5 x 80mm Polyaxial Screw, Cannulated
00840019934565Ø8.5 x 70mm Polyaxial Screw, Cannulated
00840019934558Ø8.5 x 60mm Polyaxial Screw, Cannulated
00840019934541Ø8.5 x 55mm Polyaxial Screw, Cannulated
00840019934534Ø8.5 x 50mm Polyaxial Screw, Cannulated
00840019934527Ø8.5 x 45mm Polyaxial Screw, Cannulated
00840019934510Ø8.5 x 40mm Polyaxial Screw, Cannulated
00840019934503Ø8.5 x 35mm Polyaxial Screw, Cannulated
00840019934497Ø7.5 x 80mm Polyaxial Screw, Cannulated
00840019934480Ø7.5 x 70mm Polyaxial Screw, Cannulated
00840019934473Ø7.5 x 60mm Polyaxial Screw, Cannulated
00840019934466Ø7.5 x 55mm Polyaxial Screw, Cannulated
00840019934459Ø7.5 x 50mm Polyaxial Screw, Cannulated
00840019934442Ø7.5 x 45mm Polyaxial Screw, Cannulated
00840019934435Ø7.5 x 40mm Polyaxial Screw, Cannulated
00840019934428Ø7.5 x 35mm Polyaxial Screw, Cannulated
00840019934411Ø7.5 x 30mm Polyaxial Screw, Cannulated
00840019934404Ø6.5 x 60mm Polyaxial Screw, Cannulated
00840019934398Ø6.5 x 55mm Polyaxial Screw, Cannulated
00840019934381Ø6.5 x 50mm Polyaxial Screw, Cannulated
00840019934374Ø6.5 x 45mm Polyaxial Screw, Cannulated
00840019934367Ø6.5 x 40mm Polyaxial Screw, Cannulated
00840019934350Ø6.5 x 35mm Polyaxial Screw, Cannulated
00840019934343Ø6.5 x 30mm Polyaxial Screw, Cannulated
00840019934336Ø6.5 x 25mm Polyaxial Screw, Cannulated
00840019934329Ø5.5 x 60mm Polyaxial Screw, Cannulated
00840019934312Ø5.5 x 55mm Polyaxial Screw, Cannulated
00840019934305Ø5.5 x 50mm Polyaxial Screw, Cannulated
00840019934299Ø5.5 x 45mm Polyaxial Screw, Cannulated
00840019934282Ø5.5 x 40mm Polyaxial Screw, Cannulated
00840019934275Ø5.5 x 35mm Polyaxial Screw, Cannulated
00840019934268Ø5.5 x 30mm Polyaxial Screw, Cannulated
00840019934251Ø5.5 x 25mm Polyaxial Screw, Cannulated
00840019934794Ø10.5 x 80mm Polyaxial Screw, Cannulated
00840019934787Ø10.5 x 70mm Polyaxial Screw, Cannulated
00840019934770Ø10.5 x 60mm Polyaxial Screw, Cannulated

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