Home GUDID 00840019935005 Reform Ti
Primary DI 00840019935005
Brand Reform Ti
Company PRECISION SPINE, INC.
Model 39-TD-7530
Catalog number 39-TD-7530
Device description Ø7.5 x 30mm Polyaxial Reduction Screw, Cannulated
Published 2019-10-04
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name KWP Appliance, Fixation, Spinal Interlaminal NKB Thoracolumbosacral Pedicle Screw System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWP Appliance, Fixation, Spinal Interlaminal Orthopedic 2 NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840019935005 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 00840019935005 00840019935005 840019935005 0840019935005
GMDN Terms# Term, Definition table Term Definition Spinal fixation implant/sterilization container set A collection of non-sterile, implantable components of an internal spinal fixation assembly (e.g., plates, rods, screws, connectors, and/or hooks) packaged within a reusable sterilization container (i.e., all under the same product code) to be sterilized prior to implantation. The set provides the surgeon with a selection of implants (e.g., different sizes) during surgery, whereby unused implants may be resterilised for subsequent implantation in another patient. Instruments intended to facilitate implantation may be packaged with the set. This is a reusable device which includes single-use implants.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 079398589 Device count 1 DM exempt true Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 00613994887955 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2015-09-17 00885074494722 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2015-08-05 00885074494722 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2015-08-05 00613994568311 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2015-08-05 00613994568311 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2015-08-05 00613994568823 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2015-08-05 00613994568823 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2015-08-05 00613994888143 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2015-08-05 00613994888143 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2015-08-05 04546540147257 XIA II Stryker Corporation KWP 2014-12-08 04546540147257 XIA II Stryker Corporation NKB 2014-12-08 04546540147769 XIA II Stryker Corporation KWP 2014-12-08 04546540147769 XIA II Stryker Corporation NKB 2014-12-08 04546540147806 XIA II Stryker Corporation KWP 2014-12-08 04546540147806 XIA II Stryker Corporation NKB 2014-12-08 04546540147905 XIA II Stryker Corporation KWP 2014-12-08 04546540147905 XIA II Stryker Corporation NKB 2014-12-08 04546540147912 XIA I Stryker Corporation NKB 2014-12-08 04546540147912 XIA I Stryker Corporation KWP 2014-12-08 04546540147929 XIA I Stryker Corporation KWP 2014-12-08 04546540147929 XIA I Stryker Corporation NKB 2014-12-08 04546540147936 XIA I Stryker Corporation KWP 2014-12-08 04546540147936 XIA I Stryker Corporation NKB 2014-12-08 04546540147974 XIA I Stryker Corporation KWP 2014-12-08 04546540147974 XIA I Stryker Corporation NKB 2014-12-08 04546540147981 XIA I Stryker Corporation KWP 2014-12-08