Home GUDID M697T08500131 Xspan Laminoplasty Fixation System
Primary DI M697T08500131
Brand Xspan Laminoplasty Fixation System
Company Xtant Medical Holdings, Inc.
Model T085-0013
Device description LAMINA HOLDER, ANGLED
Published 2016-06-29
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true 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 M697T08500130 Direct Marking HIBCC 0 M697T08500131 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Spinal fixation plate, non-bioabsorbable A small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization as part of treatment of a spinal instability or deformity; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 081224143 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 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 B8034709310 ORTHOMED ORTHO-MED, INC. HTC 2026-03-30 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
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