Home GUDID B946NF10050 NuFix
Primary DI B946NF10050
Brand NuFix
Company Nutech Spine, Inc.
Model IR
Catalog number NF-1005
Device description NuFix Inserter
Published 2020-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name LXH Orthopedic Manual Surgical Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B946NF10050 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Orthopaedic implant inserter/extractor, reusable A hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 080867996 Device count 1 Premarket exempt true Lot or batch 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 00810166522816 Expanding Innovations EXPANDING INNOVATIONS, INC. LXH 2026-05-27 00810166522823 Expanding Innovations EXPANDING INNOVATIONS, INC. LXH 2026-05-27 00810166522830 Expanding Innovations EXPANDING INNOVATIONS, INC. LXH 2026-05-27 00810166522847 Expanding Innovations EXPANDING INNOVATIONS, INC. LXH 2026-05-27 00810166522854 Expanding Innovations EXPANDING INNOVATIONS, INC. LXH 2026-05-27 00810166522861 Expanding Innovations EXPANDING INNOVATIONS, INC. LXH 2026-05-27 00810166522878 Expanding Innovations EXPANDING INNOVATIONS, INC. LXH 2026-05-27 00889929072424 Matrixx System NEXXT SPINE, LLC LXH 2026-05-27 07640187918809 Straight reamer handle MPS Micro Precision Systems AG LXH 2026-05-27 07613327007114 ES2 SPINAL SYSTEM Stryker Corporation LXH 2019-11-25 07613327007558 XIA 3 Stryker Corporation LXH 2019-11-25 07613327007565 XIA 3 Stryker Corporation LXH 2019-11-25 07613327114881 XIA 4.5 EVOLUTION Stryker Corporation LXH 2019-11-25 07613327121919 XIA 4.5 EVOLUTION Stryker Corporation LXH 2019-11-25 07613327126273 AVS Anchor-C Cervical Cage System Stryker Corporation LXH 2019-11-25 07613327142662 XIA 4.5 EVOLUTION Stryker Corporation LXH 2019-11-25 07613327142679 XIA 4.5 EVOLUTION Stryker Corporation LXH 2019-11-25 07613327177480 OASYS Stryker Corporation LXH 2019-11-25 07613327261752 DIAPASON Stryker Corporation LXH 2019-11-25 07613327261943 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327261950 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327261967 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327261974 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327261998 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327262001 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327262018 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327262025 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327262032 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327262049 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327262056 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25