Reform Ti Modular HA Pedicle Screw System 39-HM-8535

GUDID 00840019939638

8.5mm x 35mm Modular Bone Screw

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile
Primary Device ID00840019939638
NIH Device Record Keyfb261acd-93bf-4a39-a65b-0db2a059dc6b
Commercial Distribution StatusIn Commercial Distribution
Brand NameReform Ti Modular HA Pedicle Screw System
Version Model Number39-HM-8535
Catalog Number39-HM-8535
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
GS100840019939638 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAppliance, Fixation, Spinal Interlaminal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019939638]

Moist Heat or Steam Sterilization


[00840019939638]

Moist Heat or Steam Sterilization


[00840019939638]

Moist Heat or Steam Sterilization


[00840019939638]

Moist Heat or Steam Sterilization


[00840019939638]

Moist Heat or Steam Sterilization


[00840019939638]

Moist Heat or Steam Sterilization


[00840019939638]

Moist Heat or Steam Sterilization


[00840019939638]

Moist Heat or Steam Sterilization


[00840019939638]

Moist Heat or Steam Sterilization


[00840019939638]

Moist Heat or Steam Sterilization


[00840019939638]

Moist Heat or Steam Sterilization


[00840019939638]

Moist Heat or Steam Sterilization


[00840019939638]

Moist Heat or Steam Sterilization


[00840019939638]

Moist Heat or Steam Sterilization


[00840019939638]

Moist Heat or Steam Sterilization


[00840019939638]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-07
Device Publish Date2021-06-29

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008400199395086.5mm x 45mm Modular Bone Screw
008400199394926.5mm x 40mm Modular Bone Screw
008400199394856.5mm x 35mm Modular Bone Screw
008400199394786.5mm x 30mm Modular Bone Screw
008400199394616.5mm x 25mm Modular Bone Screw
008400199394545.5mm x 60mm Modular Bone Screw
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008400199393935.5mm x 30mm Modular Bone Screw
008400199393865.5mm x 25mm Modular Bone Screw
008400199393794.5mm x 45mm Modular Bone Screw
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008400199393554.5mm x 35mm Modular Bone Screw
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008400199397138.5mm x 90mm Modular Bone Screw
008400199397068.5mm x 80mm Modular Bone Screw
008400199396908.5mm x 70mm Modular Bone Screw
008400199396838.5mm x 60mm Modular Bone Screw
008400199396768.5mm x 55mm Modular Bone Screw
008400199396698.5mm x 50mm Modular Bone Screw
008400199396528.5mm x 45mm Modular Bone Screw
008400199396458.5mm x 40mm Modular Bone Screw
008400199396388.5mm x 35mm Modular Bone Screw
008400199396217.5mm x 80mm Modular Bone Screw
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008400199396077.5mm x 60mm Modular Bone Screw
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008400199395847.5mm x 50mm Modular Bone Screw
008400199395777.5mm x 45mm Modular Bone Screw
008400199395607.5mm x 40mm Modular Bone Screw
008400199395537.5mm x 35mm Modular Bone Screw
008400199395467.5mm x 30mm Modular Bone Screw
008400199395396.5mm x 60mm Modular Bone Screw
008400199395226.5mm x 55mm Modular Bone Screw
008400199395156.5mm x 50mm Modular Bone Screw
008400199397759.5mm x 50mm Modular Bone Screw
008400199397689.5mm x 45mm Modular Bone Screw
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00840019957991Ø9.5 mm x 100mm Modular Bone Screw, Cannulated
00840019957984Ø9.5 mm x 90mm Modular Bone Screw, Cannulated
00840019957847Ø8.5 mm x 60mm Modular Bone Screw, Cannulated
00840019957830Ø8.5 mm x 55mm Modular Bone Screw, Cannulated
00840019957823Ø8.5 mm x 50mm Modular Bone Screw, Cannulated

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