Home GUDID M697X06004820 Axle Interspinous Fusion System
Primary DI M697X06004820
Brand Axle Interspinous Fusion System
Company Xtant Medical Holdings, Inc.
Model X060-0482
Device description Grip-Lock Inserter, Cross Bar Plate, Right Handle
Published 2015-05-26
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 HTC PLIERS, SURGICAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTC Pliers, Surgical General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M697X06004820 Direct Marking HIBCC 0 M697X06004821 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Lumbar interspinous decompression instrument set, reusable A collection of surgical instruments and devices intended to be used for the implantation of an interspinous process decompression (IPD) implant that is inserted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures; this is typically to treat a patient suffering from symptomatic degenerative lumbar spinal stenosis (DLSS). It typically consists of a tray, dedicated dilators, a sizing instrument, a spacer (the implant) insertion instrument, implant holders, and a torque-limiting screwdriver. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 081224143 Device count 1 DM exempt false Premarket exempt true 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 B8034605720 ORTHOMED ORTHO-MED, INC. HTC 2026-07-14 B8034605730 ORTHOMED ORTHO-MED, INC. HTC 2026-07-14 B8034605740 ORTHOMED ORTHO-MED, INC. HTC 2026-07-14 B8034709290 ORTHOMED ORTHO-MED, INC. HTC 2026-07-14 B8034802540 ORTHOMED ORTHO-MED, INC. HTC 2026-07-14 B8034802570 ORTHOMED ORTHO-MED, INC. HTC 2026-07-14 B8034802580 ORTHOMED ORTHO-MED, INC. HTC 2026-07-14 10887587077628 NA Synthes GmbH HTC 2024-08-21 B356KJ666140 American Medicals American Medicals HTC 2024-07-11 10840199539458 Forcep KOROS U.S.A., INC. HTC 2024-02-01 10840199539489 Forcep KOROS U.S.A., INC. HTC 2024-02-01 10840199535900 Clamp KOROS U.S.A., INC. HTC 2024-01-31 10840199535962 C Clamp KOROS U.S.A., INC. HTC 2024-01-31 10840199535993 Aortic Clamp KOROS U.S.A., INC. HTC 2024-01-31 10840199536006 Aortic Clamp KOROS U.S.A., INC. HTC 2024-01-31 00841435121621 Tecomet TECOMET INC. HTC 2023-07-20 B356KJ526120 American Medicals American Medicals HTC 2022-12-14 14026704799135 PILLING TELEFLEX INCORPORATED HTC 2022-12-08 14026704799142 PILLING TELEFLEX INCORPORATED HTC 2022-12-08 14026704799159 PILLING TELEFLEX INCORPORATED HTC 2022-12-08 14026704799166 PILLING TELEFLEX INCORPORATED HTC 2022-12-08 14026704799319 PILLING TELEFLEX INCORPORATED HTC 2022-12-08 14026704799326 PILLING TELEFLEX INCORPORATED HTC 2022-12-08 14026704811448 PILLING TELEFLEX INCORPORATED HTC 2022-12-08 10840199539830 Forceps KOROS U.S.A., INC. HTC 2022-10-31 10840199539847 Forceps KOROS U.S.A., INC. HTC 2022-10-31 10840199539854 Forceps KOROS U.S.A., INC. HTC 2022-10-31 10840199539861 Forceps KOROS U.S.A., INC. HTC 2022-10-31 10840199539878 Forceps KOROS U.S.A., INC. HTC 2022-10-31 10840199539885 Forceps KOROS U.S.A., INC. HTC 2022-10-31
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