Reform POCT System 55-TH-0102

GUDID 00815362024546

Ø6.0mm, Straight Hook

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00815362024546
NIH Device Record Key45cd868e-2462-4299-a3ec-b30fedb644cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameReform POCT System
Version Model Number55-TH-0102
Catalog Number55-TH-0102
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
GS100815362024546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKGPosterior Cervical Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00815362024546]

Moist Heat or Steam Sterilization

[00815362024546]

Moist Heat or Steam Sterilization

[00815362024546]

Moist Heat or Steam Sterilization

[00815362024546]

Moist Heat or Steam Sterilization

[00815362024546]

Moist Heat or Steam Sterilization

[00815362024546]

Moist Heat or Steam Sterilization

[00815362024546]

Moist Heat or Steam Sterilization

[00815362024546]

Moist Heat or Steam Sterilization

[00815362024546]

Moist Heat or Steam Sterilization

[00815362024546]

Moist Heat or Steam Sterilization

[00815362024546]

Moist Heat or Steam Sterilization

[00815362024546]

Moist Heat or Steam Sterilization

[00815362024546]

Moist Heat or Steam Sterilization

[00815362024546]

Moist Heat or Steam Sterilization

[00815362024546]

Moist Heat or Steam Sterilization

[00815362024546]

Moist Heat or Steam Sterilization

[00815362024546]

Moist Heat or Steam Sterilization

[00815362024546]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-13
Device Publish Date2019-05-03

On-Brand Devices [Reform POCT System ]

00815362024621Ø3.5 x 25mm Lateral Offset, Open
00815362024614Ø3.5 x 15mm Lateral Offset, Open
00815362024607Ø3.5 x 25mm Lateral Offset, Closed
00815362024591Ø3.5 x 15mm Lateral Offset, Closed
00815362024584Ø6.0mm, Supra Laminar Offset Hook Left
00815362024577Ø6.0mm, Supra Lamniar Offset Hook Right
00815362024560Ø6.0mm, Offset Hook Left
00815362024553Ø6.0mm, Offset Hook Right
00815362024546Ø6.0mm, Straight Hook
00815362024539Ø4.5mm, Supra Laminar Offset Hook Left
00815362024515Ø4.5mm, Offset Hook Left
00815362024508Ø4.5mm, Offset Hook Right
00815362024485Ø4.0 x 40mm Smooth Shank Screw
00815362024478Ø4.0 x 38mm Smooth Shank Screw
00815362024461Ø4.0 x 36mm Smooth Shank Screw
00815362024454Ø4.0 x 34mm Smooth Shank Screw
00815362024447Ø4.0 x 32mm Smooth Shank Screw
00815362024430Ø4.0 x 30mm Smooth Shank Screw
00815362024423Ø4.0 x 28mm Smooth Shank Screw
00815362024416Ø4.0 x 26mm Smooth Shank Screw
00815362024409Ø4.0 x 24mm Smooth Shank Screw
00815362024393Ø4.0 x 22mm Smooth Shank Screw
00815362024386Ø4.0 x 20mm Smooth Shank Screw
00815362024379Ø3.5 x 40mm Smooth Shank Screw
00815362024362Ø3.5 x 38mm Smooth Shank Screw
00815362024355Ø3.5 x 36mm Smooth Shank Screw
00815362024348Ø3.5 x 34mm Smooth Shank Screw
00815362024331Ø3.5 x 32mm Smooth Shank Screw
00815362024324Ø3.5 x 30mm Smooth Shank Screw
00815362024317Ø3.5 x 28mm Smooth Shank Screw
00815362024300Ø3.5 x 26mm Smooth Shank Screw
00815362024294Ø3.5 x 24mm Smooth Shank Screw
00815362024287Ø3.5 x 22mm Smooth Shank Screw
00815362024270Ø3.5 x 20mm Smooth Shank Screw
00815362024263Ø4.5 x 50mm Polyaxial Screw
00815362024256Ø4.5 x 45mm Polyaxial Screw
00815362024249Ø4.5 x 40mm Polyaxial Screw
00815362024232Ø4.5 x 35mm Polyaxial Screw
00815362024225Ø4.5 x 30mm Polyaxial Screw
00815362024218Ø4.5 x 25mm Polyaxial Screw
00815362024201Ø4.5 x 20mm Polyaxial Screw
00815362024195Ø4.0 x 40mm Polyaxial Screw
00815362024188Ø4.0 x 35mm Polyaxial Screw
00815362024171Ø4.0 x 30mm Polyaxial Screw
00815362024164Ø4.0 x 28mm Polyaxial Screw
00815362024157Ø4.0 x 26mm Polyaxial Screw
00815362024140Ø4.0 x 24mm Polyaxial Screw
00815362024133Ø4.0 x 22mm Polyaxial Screw
00815362024126Ø4.0 x 20mm Polyaxial Screw
00815362024119Ø4.0 x 18mm Polyaxial Screw
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