SURE LOK (TM) 43-TL-6555

GUDID 00815362022870

MD MAX TRIPLE LEAD 6.5 x 55 MM (QTY 23)

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00815362022870
NIH Device Record Key2915917c-81f3-4abf-aa31-53bd337fd8dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameSURE LOK (TM)
Version Model Number7684PS
Catalog Number43-TL-6555
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
GS100815362022870 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIOrthosis, Spinal Pedicle Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


[00815362022870]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-01

On-Brand Devices [SURE LOK (TM)]

00815362023013MD MAX TRIPLE LEAD 7.5 x 55MM (QTY 23)
00815362023006MD MAX TRIPLE LEAD 7.5 x 55MM (QTY 19)
00815362022993MD MAX TRIPLE LEAD 7.5 x 50MM (QTY 20)
00815362022986MD MAX TRIPLE LEAD 7.5 x 45MM (QTY 19)
00815362022979MD MAX TRIPLE LEAD 7.5 x 50MM (QTY 25)
00815362022962MD MAX TRIPLE LEAD 7.5 x 45MM (QTY 20)
00815362022955MD MAX TRIPLE LEAD 7.5x45m (QTY 27)
00815362022948MD MAX TRIPLE LEAD 7.5x40MM (QTY15)
00815362022931MD MAX TRIPLE LEAD 7.5x40mm (QTY 9)
00815362022924MD MAX TRIPLE LEAD 7.5x35mm (QTY 22)
00815362022917MD MAX TRIPLE LEAD 7.5x35mm (QTY 28)
00815362022900MD MAX TRIPLE LEAD 6.5 x 55MM (QTY 21)
00815362022894MD MAX TRIPLE LEAD 6.5x55mm (QTY 24)
00815362022887MD MAX TRIPLE LEAD SCREW 6.5 x 55MM (QTY 62)
00815362022870MD MAX TRIPLE LEAD 6.5 x 55 MM (QTY 23)
00815362022863MD MAX TRIPLE LEAD 6.5 x 50MM (QTY 13)
00815362022856MD MAX TRIPLE LEAD 6.5x50MM (QTY 46)
00815362022849MD MAXTRIPLE LEAD 5.5x55MM (QTY 9)
00815362022832MD MAX TRIPLE LEAD 5.5x55MM (QTY 40)
00815362022825MD MAX TRIPLE LEAD 5.5 x 50 MM (QTY 28)

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