REFORM 39-RU-4540

GUDID 00815362029534

Reform Uniplanar Screw 4.5 x 40mm (Qty 25)

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00815362029534
NIH Device Record Key545c1180-34a1-4c17-ae84-eb70772c172b
Commercial Distribution StatusIn Commercial Distribution
Brand NameREFORM
Version Model Number00758RM
Catalog Number39-RU-4540
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
GS100815362029534 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIOrthosis, Spinal Pedicle Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00815362029534]

Moist Heat or Steam Sterilization


[00815362029534]

Moist Heat or Steam Sterilization


[00815362029534]

Moist Heat or Steam Sterilization


[00815362029534]

Moist Heat or Steam Sterilization


[00815362029534]

Moist Heat or Steam Sterilization


[00815362029534]

Moist Heat or Steam Sterilization


[00815362029534]

Moist Heat or Steam Sterilization


[00815362029534]

Moist Heat or Steam Sterilization


[00815362029534]

Moist Heat or Steam Sterilization


[00815362029534]

Moist Heat or Steam Sterilization


[00815362029534]

Moist Heat or Steam Sterilization


[00815362029534]

Moist Heat or Steam Sterilization


[00815362029534]

Moist Heat or Steam Sterilization


[00815362029534]

Moist Heat or Steam Sterilization


[00815362029534]

Moist Heat or Steam Sterilization


[00815362029534]

Moist Heat or Steam Sterilization


[00815362029534]

Moist Heat or Steam Sterilization


[00815362029534]

Moist Heat or Steam Sterilization


[00815362029534]

Moist Heat or Steam Sterilization


[00815362029534]

Moist Heat or Steam Sterilization


[00815362029534]

Moist Heat or Steam Sterilization


[00815362029534]

Moist Heat or Steam Sterilization


[00815362029534]

Moist Heat or Steam Sterilization


[00815362029534]

Moist Heat or Steam Sterilization


[00815362029534]

Moist Heat or Steam Sterilization


[00815362029534]

Moist Heat or Steam Sterilization


[00815362029534]

Moist Heat or Steam Sterilization


[00815362029534]

Moist Heat or Steam Sterilization


[00815362029534]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-05

On-Brand Devices [REFORM ]

00815362029992Reform Polyaxial Screw 8.5 x 55MM (QTY 85)
00815362029985Reform Polyaxial Screw 8.5 x 50MM (QTY 38)
00815362029978Reform Polyaxial Screw 8.5 x 50MM (QTY 101)
00815362029961Reform Polyaxial Screw 7.5 x 55MM (QTY 120)
00815362029954Reform Polyaxial Screw 7.5 x 55MM (QTY 42)
00815362029947Reform Polyaxial Screw 7.5 x 55MM (QTY 24 )
00815362029930Reform Polyaxial Screw 7.5 x 50MM (QTY200 )
00815362029923Reform Polyaxial Screw 7.5 x 40MM (QTY 239)
00815362029916Reform Polyaxial Screw 6.5 x 55MM (QTY 226)
00815362029909Reform Polyaxial Screw 6.5 x 55MM (QTY 101)
00815362029893Reform Polyaxial Screw 6.5 x 55MM (QTY 79)
00815362029886Reform Polyaxial Screw 6.5 x 55MM (QTY 98)
00815362029879Reform Polyaxial Screw 6.5 x 50MM (QTY 276)
00815362029862Reform Polyaxial Screw 6.5 x 50MM (QTY 250)
00815362029855Reform Polyaxial Screw 6.5 x 50MM (QTY 200)
00815362029848Reform Polyaxial Screw 6.5 x 50MM (QTY 101)
00815362029831Reform Polyaxial Screw 6.5 x 35MM (QTY191 )
00815362029824Reform Uniplanar Screw 6.5 x 30MM (QTY 100)
00815362029701Reform Hex Rod End Rod 5.5mm (QTY 30)
00815362029695Reform Hook Angled Hook, MD, Right (QTY 16)
00815362029688Reform Uniplanar Screw 5.5 x 30mm (QTY 126)
00815362029671Reform Uniplanar Screw 5.5 x 25mm (QTY 35)
00815362029657Reform Uniplanar Screw 6.5 x 45MM (QTY 50)
00815362029640Reform Uniplanar Screw 6.5.x40 MM (QTY 46 )
00815362029633Reform Uniplanar Screw 6.5 x 40MM (QTY 100 )
00815362029626Reform Uniplanar Screw 6.5 x 35MM (QTY 100)
00815362029619Reform Uniplanar Screw 6.5 x 30MM (QTY 3)
00815362029602Reform Uniplanar Screw 6.5 x 30MM (QTY 73)
00815362029596Reform Uniplanar Screw 5.5 x 45MM (QTY 67)
00815362029589Reform Uniplanar Screw 5.5 x 40MM (QTY 108)
00815362029572Reform Uniplanar Screw 5.5 x 35MM (QTY98)
00815362029565Reform Uniplanar Screw 5.5 x 35MM (QTY 98)
00815362029558Reform Uniplanar Screw 5.5 x 30MM (QTY 26)
00815362029541Reform Uniplanar Screw 5.5 x 30mm (Qty 40)
00815362029534Reform Uniplanar Screw 4.5 x 40mm (Qty 25)
00815362029527Reform Uniplanar Screw 4.5 x 35MM (QTY 39)
00815362029510Reform Uniplanar Screw 4.5 x 30MM (QTY 40)
00815362029503Reform Uniplanar Screw 4.5 X 25 mm (QTY 37)
00815362024034REFORM LATERAL OFFSET 20mm (qty 9)

Trademark Results [REFORM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
REFORM
REFORM
98203546 not registered Live/Pending
Loveland Products, Inc.
2023-09-29
REFORM
REFORM
98089366 not registered Live/Pending
Loveland Products, Inc.
2023-07-18
REFORM
REFORM
98081488 not registered Live/Pending
Winpak Ltd.
2023-07-12
REFORM
REFORM
97783633 not registered Live/Pending
9376-1377 Québec inc.
2023-02-07
REFORM
REFORM
97661242 not registered Live/Pending
Reform LLC
2022-11-03
REFORM
REFORM
97491288 not registered Live/Pending
Baker Hughes Holdings LLC
2022-07-06
REFORM
REFORM
90844523 not registered Live/Pending
Incase Designs Corp.
2021-07-23
REFORM
REFORM
90702763 not registered Live/Pending
Reform Group Holdings ApS
2021-05-11
REFORM
REFORM
90702754 not registered Live/Pending
Reform Group Holdings ApS
2021-05-11
REFORM
REFORM
90281099 not registered Live/Pending
Criminal Justice Reform Foundation
2020-10-27
REFORM
REFORM
88933318 not registered Live/Pending
Loveland Products, Inc.
2020-05-26
REFORM
REFORM
88668615 not registered Live/Pending
Reform Unlimited
2019-10-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.