SureLOK MIS 3L 63-ST-5130

GUDID 00840019906067

CL Percutaneous Straight Ti Rod, 5.5mm x 130mm

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840019906067
NIH Device Record Key91144b86-a7bb-4c3b-9b78-8f8eeadb105f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSureLOK MIS 3L
Version Model Number63-ST-5130
Catalog Number63-ST-5130
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
GS100840019906067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIOrthosis, Spinal Pedicle Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019906067]

Moist Heat or Steam Sterilization


[00840019906067]

Moist Heat or Steam Sterilization


[00840019906067]

Moist Heat or Steam Sterilization


[00840019906067]

Moist Heat or Steam Sterilization


[00840019906067]

Moist Heat or Steam Sterilization


[00840019906067]

Moist Heat or Steam Sterilization


[00840019906067]

Moist Heat or Steam Sterilization


[00840019906067]

Moist Heat or Steam Sterilization


[00840019906067]

Moist Heat or Steam Sterilization


[00840019906067]

Moist Heat or Steam Sterilization


[00840019906067]

Moist Heat or Steam Sterilization


[00840019906067]

Moist Heat or Steam Sterilization


[00840019906067]

Moist Heat or Steam Sterilization


[00840019906067]

Moist Heat or Steam Sterilization


[00840019906067]

Moist Heat or Steam Sterilization


[00840019906067]

Moist Heat or Steam Sterilization


[00840019906067]

Moist Heat or Steam Sterilization


[00840019906067]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-17
Device Publish Date2019-04-09

On-Brand Devices [SureLOK MIS 3L]

00840019920322Caddy, CL Straight Rod Ti, 35-90mm
00840019920315Caddy, CL Straight Rod Ti, 100-150mm
00840019920292Caddy, Straight Rod 100-150mm
00840019920285Caddy, CL Curved Rod Titanium
00840019920278Caddy, Curved Rod Titanium
00840019920261Insturment Case w/ Pin Mat
00840019920254Implant Case 2
00840019920247Implant Case 1
00840019920223Instrument Case - M
00840019920216MIS 3L Serial Dilator, 24mm
00840019920209MIS 3L Serial Dilator, 18mm
00840019920193MIS 3L Serial Dilator, 13mm
00840019920179CL Rod Inserter
00840019920162Ring
00840019920155CL Counter Torque Handle
00840019920148Reduction Driver
00840019920131Reducer Dock
00840019920124Compression-Distraction Arm B2
00840019920117Compression-Distraction Arm B1
00840019920100Compression-Distraction Arm A
00840019920094Bifurcated Tap, 8.5mm
00840019920087Bifurcated Tap, 7.5mm
00840019920070Bifurcated Tap, 6.5mm
00840019920063Bifurcated Tap, 5.5mm
00840019920056Guide Wire Inserter/Extractor
00840019920032Counter Torque Handle
00840019920025Compressor-Distractor Arm B
00840019920018Compressor-Distractor Arm A
00840019920001Reducer Extender
00840019919999Rod Reducer
00840019919982C-Torque, Sleeve
00840019919975Bottle Cap
00840019919951Torque Drive Shaft
00840019919944Rod Inserter, Side Load
00840019919920Percutaneous Screwdriver, Short
00840019919913Tower Sleeve
00840019919906Ratcheting Palm Handle
00840019919883Tap Dilator
00840019920308Caddy, Straight Rod 35-90mm
00840019920230Instrument Case
00840019920186MIS 3L Serial Dilator, 8mm
00840019920049T-Handle, Reduction Tower
00840019919968Tower Tube Removal Tool
00840019919937Rod Inserter Tightener
00840019919890Biforcated Taps
00840019905749Pedicle Screw Ø8.5 x 100mm
00840019905732Pedicle Screw Ø8.5 x 90mm
00840019905725Pedicle Screw Ø8.5 x 80mm
00840019905718Pedicle Screw Ø8.5 x 70mm
00840019905701Pedicle Screw Ø8.5 x 60mm

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