Home GUDID 00840019907460 SureLOK Mini Posterior Cervical/Upper Thoracic System
Primary DI 00840019907460
Brand SureLOK Mini Posterior Cervical/Upper Thoracic System
Company PRECISION SPINE, INC.
Model 04-1000
Catalog number 04-1000
Device description Mini SureLOK™ Cap Screw
Published 2019-04-10
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name KWP Appliance, Fixation, Spinal Interlaminal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWP Appliance, Fixation, Spinal Interlaminal Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840019907460 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00840019907460 00840019907460 840019907460 0840019907460
GMDN Terms# Term, Definition table Term Definition Bone-screw internal spinal fixation system, non-sterile An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 079398589 Device count 1 DM exempt true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840606186544 OMEGA XP SPINAL ELEMENTS, INC. KWP 2026-09-22 00840606186551 OMEGA XP SPINAL ELEMENTS, INC. KWP 2026-09-22 00613994738646 ZEPHIR® Anterior Cervical System MEDTRONIC SOFAMOR DANEK, INC. KWP 2019-03-07 00613994887955 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2015-09-17 00885074494722 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2015-08-05 00613994568311 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2015-08-05 00613994568823 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2015-08-05 00613994888143 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2015-08-05 04546540147257 XIA II Stryker Corporation KWP 2014-12-08 04546540147769 XIA II Stryker Corporation KWP 2014-12-08 04546540147806 XIA II Stryker Corporation KWP 2014-12-08 04546540147905 XIA II Stryker Corporation KWP 2014-12-08 04546540147912 XIA I Stryker Corporation KWP 2014-12-08 04546540147929 XIA I Stryker Corporation KWP 2014-12-08 04546540147936 XIA I Stryker Corporation KWP 2014-12-08 04546540147974 XIA I Stryker Corporation KWP 2014-12-08 04546540147981 XIA I Stryker Corporation KWP 2014-12-08 04546540147998 XIA I Stryker Corporation KWP 2014-12-08 04546540148001 XIA II Stryker Corporation KWP 2014-12-08 04546540148018 XIA II Stryker Corporation KWP 2014-12-08 04546540148025 XIA II Stryker Corporation KWP 2014-12-08 04546540148735 XIA II Stryker Corporation KWP 2014-12-08 04546540148742 XIA II Stryker Corporation KWP 2014-12-08 04546540148759 XIA II Stryker Corporation KWP 2014-12-08 04546540148766 XIA II Stryker Corporation KWP 2014-12-08 04546540148773 XIA II Stryker Corporation KWP 2014-12-08 04546540148780 XIA II Stryker Corporation KWP 2014-12-08 04546540148797 XIA II Stryker Corporation KWP 2014-12-08 04546540148803 XIA II Stryker Corporation KWP 2014-12-08 04546540148810 XIA II Stryker Corporation KWP 2014-12-08