Reform TI Pedicle Screw System 39-BK-1708

GUDID 00840019935821

Cannulated Implant Kit: Std + Outlier Ply + Red (Cr)

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840019935821
NIH Device Record Key92a7f768-ebed-45a1-894a-56dede27939b
Commercial Distribution StatusIn Commercial Distribution
Brand NameReform TI Pedicle Screw System
Version Model Number39-BK-1708
Catalog Number39-BK-1708
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 Usefalse
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
GS100840019935821 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIOrthosis, Spinal Pedicle Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019935821]

Moist Heat or Steam Sterilization


[00840019935821]

Moist Heat or Steam Sterilization


[00840019935821]

Moist Heat or Steam Sterilization


[00840019935821]

Moist Heat or Steam Sterilization


[00840019935821]

Moist Heat or Steam Sterilization


[00840019935821]

Moist Heat or Steam Sterilization


[00840019935821]

Moist Heat or Steam Sterilization


[00840019935821]

Moist Heat or Steam Sterilization


[00840019935821]

Moist Heat or Steam Sterilization


[00840019935821]

Moist Heat or Steam Sterilization


[00840019935821]

Moist Heat or Steam Sterilization


[00840019935821]

Moist Heat or Steam Sterilization


[00840019935821]

Moist Heat or Steam Sterilization


[00840019935821]

Moist Heat or Steam Sterilization


[00840019935821]

Moist Heat or Steam Sterilization


[00840019935821]

Moist Heat or Steam Sterilization


[00840019935821]

Moist Heat or Steam Sterilization


[00840019935821]

Moist Heat or Steam Sterilization


[00840019935821]

Moist Heat or Steam Sterilization


[00840019935821]

Moist Heat or Steam Sterilization


[00840019935821]

Moist Heat or Steam Sterilization


[00840019935821]

Moist Heat or Steam Sterilization


[00840019935821]

Moist Heat or Steam Sterilization


[00840019935821]

Moist Heat or Steam Sterilization


[00840019935821]

Moist Heat or Steam Sterilization


[00840019935821]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-11
Device Publish Date2019-09-03

On-Brand Devices [Reform TI Pedicle Screw System]

00840019937252Instrument Kit 1
00840019937245Implant Kit: Std + Outlier Ply + Red (Cr)
00840019937238Implant Kit: Std + Red (Cr)
00840019937221Implant Kit: Std + Outlier Ply (Cr)
00840019937214Implant Kit: Std: 5.5 - 7.5 Ply (Cr)
00840019937207Implant Kit: Std + Outlier Ply + Red (Ti)
00840019937184Implant Kit: Std + Outlier Ply (Ti)
00840019937177Implant Kit: Std: 5.5 - 7.5 Ply (Ti)
00840019935883Reduction Cannulated Polyaxial Screw Caddy
00840019935876Outlier Cannulated Polyaxial Screw Caddy
00840019935869ø7.5mm Cannulated Polyaxial Screw Caddy
00840019935852ø6.5mm Cannulated Polyaxial Screw Caddy
00840019935845ø5.5mm Cannulated Polyaxial Screw Caddy
00840019935838Cannulated Instrument Kit 1
00840019935821Cannulated Implant Kit: Std + Outlier Ply + Red (Cr)
00840019935814Cannulated Implant Kit: Std + Red (Cr)
00840019935807Cannulated Implant Kit: Std + Outlier Ply (Cr)
00840019935784Cannulated Implant Kit: Std + Outlier Ply + Red (Ti)
00840019935777Cannulated Implant Kit: Std + Red (Ti)
00840019935760Cannulated Implant Kit: Std + Outlier Ply (Ti)
00840019935753Cannulated Implant Kit: Std: 5.5 - 7.5 Ply (Ti)
00840019929226Reduction Polyaxial Screw Caddy
00840019929219Outlier Polyaxial Screw Caddy
00840019929202ø7.5mm Polyaxial Screw Caddy
00840019929196ø6.5mm Polyaxial Screw Caddy
00840019929189ø5.5mm Polyaxial Screw Caddy
00840019929172Polyaxial Driver
00840019929165Retention Bone-Screw Driver
008400199036539.5 x 90mm Reduction Polyaxial Screw
008400199036469.5 x 80mm Reduction Polyaxial Screw
008400199036399.5 x 70mm Reduction Polyaxial Screw
008400199036229.5 x 60mm Reduction Polyaxial Screw
008400199036159.5 x 55mm Reduction Polyaxial Screw
008400199036089.5 x 50mm Reduction Polyaxial Screw
008400199035929.5 x 45mm Reduction Polyaxial Screw
008400199035859.5 x 40mm Reduction Polyaxial Screw
008400199035789.5 x 120mm Reduction Polyaxial Screw
008400199035619.5 x 110mm Reduction Polyaxial Screw
008400199035549.5 x 100mm Reduction Polyaxial Screw
008400199035478.5 x 90mm Reduction Polyaxial Screw
008400199035308.5 x 80mm Reduction Polyaxial Screw
008400199035238.5 x 70mm Reduction Polyaxial Screw
008400199035168.5 x 60mm Reduction Polyaxial Screw
008400199035098.5 x 55mm Reduction Polyaxial Screw
008400199034938.5 x 50mm Reduction Polyaxial Screw
008400199034868.5 x 45mm Reduction Polyaxial Screw
008400199034798.5 x 40mm Reduction Polyaxial Screw
008400199034628.5 x 35mm Reduction Polyaxial Screw
008400199034558.5 x 120mm Reduction Polyaxial Screw
008400199034488.5 x 110mm Reduction Polyaxial Screw

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