SureLOK Pedicle Screw System 09-9029

GUDID 00815362022009

SureLOK MIS Tissue Cutter

PRECISION SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00815362022009
NIH Device Record Keyf1a2e4a9-0ca2-4948-ba6a-9cb6a2b99afc
Commercial Distribution StatusIn Commercial Distribution
Brand NameSureLOK Pedicle Screw System
Version Model Number09-9029
Catalog Number09-9029
Company DUNS079398589
Company NamePRECISION SPINE, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
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
GS100815362022009 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00815362022009]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-08-28
Device Publish Date2019-04-01

On-Brand Devices [SureLOK Pedicle Screw System ]

00815362023327Instrument Kit
00815362023310MIS Caliper Assembly
00815362023303Tower
00815362022009SureLOK MIS Tissue Cutter
00815362021996SureLOK MIS Locking Cap Inserter
00815362021989SureLOK MIS K-Wire Retractor
00815362021965SureLOK MIS Tower Hinge
00815362021958SureLOK MIS Rod Inserter, percutaneous
00815362021941SureLOK MIS MIS Torque Driver
00815362021934SureLOK MIS MIS Distractor
00815362021927SureLOK MIS Compressor
00815362021910SureLOK MIS Mallet
00815362021903SureLOK MIS Cannulated Awl
00815362021897SureLOK MIS ø8.5mm Cannulated Pedicle Screw Tap
00815362021873SureLOK MIS ø7.5mm Cannulated Pedicle Screw Tap
00815362021866SureLOK MIS ø6.5mm Cannulated Pedicle Screw Tap
00815362021859SureLOK MIS ø5.5mm Cannulated Pedicle Screw Tap
00815362021835SureLOK MIS Radel Dilation Tube 24mm
00815362021828SureLOK MIS Radel Dilation Tube 18mm
00815362021804SureLOK MIS Radel Dilation Tube 13mm
00815362021781SureLOK MIS Radel Dilation Tube 8mm
00815362021743SureLOK MIS Rod Reducer
00815362021736SureLOK MIS K-Wire

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