Reform Pedicle Screw System 39-CC-0035

GUDID 00815362027387

35mm Cross Connector

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00815362027387
NIH Device Record Keyc77e49e5-7092-4f3c-ad12-70b1fe6ad4e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameReform Pedicle Screw System
Version Model Number39-CC-0035
Catalog Number39-CC-0035
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 Batchfalse
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
GS100815362027387 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIOrthosis, Spinal Pedicle Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00815362027387]

Moist Heat or Steam Sterilization


[00815362027387]

Moist Heat or Steam Sterilization


[00815362027387]

Moist Heat or Steam Sterilization


[00815362027387]

Moist Heat or Steam Sterilization


[00815362027387]

Moist Heat or Steam Sterilization


[00815362027387]

Moist Heat or Steam Sterilization


[00815362027387]

Moist Heat or Steam Sterilization


[00815362027387]

Moist Heat or Steam Sterilization


[00815362027387]

Moist Heat or Steam Sterilization


[00815362027387]

Moist Heat or Steam Sterilization


[00815362027387]

Moist Heat or Steam Sterilization


[00815362027387]

Moist Heat or Steam Sterilization


[00815362027387]

Moist Heat or Steam Sterilization


[00815362027387]

Moist Heat or Steam Sterilization


[00815362027387]

Moist Heat or Steam Sterilization


[00815362027387]

Moist Heat or Steam Sterilization


[00815362027387]

Moist Heat or Steam Sterilization


[00815362027387]

Moist Heat or Steam Sterilization


[00815362027387]

Moist Heat or Steam Sterilization


[00815362027387]

Moist Heat or Steam Sterilization


[00815362027387]

Moist Heat or Steam Sterilization


[00815362027387]

Moist Heat or Steam Sterilization


[00815362027387]

Moist Heat or Steam Sterilization


[00815362027387]

Moist Heat or Steam Sterilization


[00815362027387]

Moist Heat or Steam Sterilization


[00815362027387]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-22
Device Publish Date2019-05-14

On-Brand Devices [ Reform Pedicle Screw System]

0081536202741766mm Cross Connector
0081536202740048mm Cross Connector
0081536202739440mm Cross Connector
0081536202738735mm Cross Connector
0081536202737032mm Cross Connector
0081536202736330mm Cross Connector
00815362027356Axial Domino, Cl-Cl

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