Home GUDID 00763000880248 n/a
Primary DI 00763000880248
Brand n/a
Company MEDTRONIC SOFAMOR DANEK, INC.
Model 7967084
Device description MANIPULATOR 7967084 SCREW INSERTION
Published 2025-10-20
Public version status New
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 00763000880248 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 00763000880248 00763000880248 763000880248 0763000880248
GMDN Terms# Term, Definition table Term Definition Orthopaedic bone screw starter/notcher A hand-held surgical instrument used to create an indentation or enlarge a pre-drilled pilot hole in a bone that will enable the surgeon to begin threading a bone screw or place another form of anchoring device. This device, commonly known as a bone notcher, may function and be used in a variety of ways: 1) notch the bone such that the threads on a bone screw will bite into the bone; 2) simply hold the screw at the desired angle to the bone while the screw is driven into position; or 3) in the case of hard bone (e.g., on the glenoid) be inserted into a pilot hole where it is rotated to create a cavity within the soft bone for placement of, e.g., a suture anchor. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 830350380 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 10888857615779 K2M General Instruments VB Spine LLC LXH 2026-10-28 M739193990906 Non-Modular Convex Trial CAPTIVA SPINE, INC. LXH 2026-10-28 M739193996906 Non-Modular Lordotic Trial Assembly CAPTIVA SPINE, INC. LXH 2026-10-28 M739243999005 SG Implant Driver-S CAPTIVA SPINE, INC. LXH 2026-10-28 M739985202229 Marking Pin CAPTIVA SPINE, INC. LXH 2026-10-28 M739985203229 Marking Pin CAPTIVA SPINE, INC. LXH 2026-10-28 00810055525164 NON NAVIGATED STYLET-OBTURATOR ASSEMBLY Si-Bone Inc. LXH 2026-10-27 00810055525188 CANNULATED PROBE IMPACTION CAP ASSEMBLY Si-Bone Inc. LXH 2026-10-27 00810055525195 CANNULATED PROBE HANDLE ASSEMBLY Si-Bone Inc. LXH 2026-10-27 00810055525218 GRANITE CANNULATED PROBE SHAFT Si-Bone Inc. LXH 2026-10-27 00889024702233 OsseoFit Zimmer, Inc. LXH 2026-10-27 00889024702240 OsseoFit Zimmer, Inc. LXH 2026-10-27 00889024702479 OsseoFit Zimmer, Inc. LXH 2026-10-27 00763000880118 MSB Reusable Instruments MEDTRONIC SOFAMOR DANEK, INC. LXH 2026-10-23 00842528130056 OSTEOMED OSTEOMED LLC LXH 2026-10-23 00888867550391 Arthrex® ARTHREX, INC. LXH 2026-10-23 00888867550407 Arthrex® ARTHREX, INC. LXH 2026-10-23 00888867550414 Arthrex® ARTHREX, INC. LXH 2026-10-23 00888867550421 Arthrex® ARTHREX, INC. LXH 2026-10-23 04251631412144 BEE PLIF NGMedical GmbH LXH 2026-10-23 M739153997700 Cross Connector Driver CAPTIVA SPINE, INC. LXH 2026-10-23 M739153998800 Cross Connector Counter Torque CAPTIVA SPINE, INC. LXH 2026-10-23 M739243501000 Blade Dilator CAPTIVA SPINE, INC. LXH 2026-10-23 M739243502000 Parallel Guide CAPTIVA SPINE, INC. LXH 2026-10-23 M739243503000 In-Line Handle CAPTIVA SPINE, INC. LXH 2026-10-23 M739243504000 Tissue Dilator CAPTIVA SPINE, INC. LXH 2026-10-23 M739243505000 Tissue Protector CAPTIVA SPINE, INC. LXH 2026-10-23 M739243506000 Adjustable Parallel Guide CAPTIVA SPINE, INC. LXH 2026-10-23 M739243507000 Impaction Sleeve CAPTIVA SPINE, INC. LXH 2026-10-23 M739243508000 Self-Feeding Drill CAPTIVA SPINE, INC. LXH 2026-10-23
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