Home GUDID 00814008025558 Boundary
Primary DI 00814008025558
Brand Boundary
Company NVision Biomedical Technologies, Inc.
Model BUT-1000T-DRL
Device description Instrument, Lumbar Buttress Plate Drill. The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
Published 2018-07-11
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 false
Product Codes# Code, Name table Code Name KWQ Appliance, Fixation, Spinal Intervertebral Body
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00814008025558 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 00814008025558 00814008025558 814008025558 0814008025558
GMDN Terms# Term, Definition table Term Definition General internal orthopaedic fixation system implantation kit A collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 047486041 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false 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 00810017915125 SABER-XA, Screw Ø5.0 x 22.5 ELEVATION SPINE, INC. KWQ 2026-09-22 00810017915149 SABER-XA, Screw Ø5.0 x 32.5 ELEVATION SPINE, INC. KWQ 2026-09-22 00810017915156 SABER-XA, Screw Ø5.5 x 22.5 ELEVATION SPINE, INC. KWQ 2026-09-22 00810017915163 SABER-XA, Screw Ø5.5 x 27.5 ELEVATION SPINE, INC. KWQ 2026-09-22 00810017915170 SABER-XA, Screw Ø5.5 x 32.5 ELEVATION SPINE, INC. KWQ 2026-09-22 10888857598164 Xia® 3 System - Serrato® VB Spine LLC KWQ 2026-07-24 10888857598171 Xia® 3 System - Serrato® VB Spine LLC KWQ 2026-07-24 10888857598188 Xia® 3 System - Serrato® VB Spine LLC KWQ 2026-07-24 10888857598195 Xia® 3 System - Serrato® VB Spine LLC KWQ 2026-07-24 10888857598201 Xia® 3 System - Serrato® VB Spine LLC KWQ 2026-07-24 10888857598218 Xia® 3 System - Serrato® VB Spine LLC KWQ 2026-07-24 10888857598225 Xia® 3 System - Serrato® VB Spine LLC KWQ 2026-07-24 10888857598232 Xia® 3 System - Serrato® VB Spine LLC KWQ 2026-07-24 10888857598249 Xia® 3 System - Serrato® VB Spine LLC KWQ 2026-07-24 00810056993146 corra Carlsmed, Inc. KWQ 2026-01-30 00613994568311 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWQ 2015-08-05 00613994568823 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWQ 2015-08-05 04546540147257 XIA II Stryker Corporation KWQ 2014-12-08 04546540147769 XIA II Stryker Corporation KWQ 2014-12-08 04546540147806 XIA II Stryker Corporation KWQ 2014-12-08 04546540147905 XIA II Stryker Corporation KWQ 2014-12-08 04546540147912 XIA I Stryker Corporation KWQ 2014-12-08 04546540147929 XIA I Stryker Corporation KWQ 2014-12-08 04546540147936 XIA I Stryker Corporation KWQ 2014-12-08 04546540147974 XIA I Stryker Corporation KWQ 2014-12-08 04546540147981 XIA I Stryker Corporation KWQ 2014-12-08 04546540147998 XIA I Stryker Corporation KWQ 2014-12-08 04546540148001 XIA II Stryker Corporation KWQ 2014-12-08 04546540148018 XIA II Stryker Corporation KWQ 2014-12-08 04546540148025 XIA II Stryker Corporation KWQ 2014-12-08