Home GUDID M697C07800220 H-graft Interspinous Allograft
Primary DI M697C07800220
Brand H-graft Interspinous Allograft
Company Xtant Medical Holdings, Inc.
Model C078-0022
Device description Sm. H-Graft Distractor
Published 2018-06-18
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 HWB Extractor
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HWB Extractor Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M697C07800220 Direct Marking HIBCC 0 M697C07800221 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Cadaveric-donor bone allograft Bone intended for transplantation that is harvested from a cadaveric human donor genetically different from the human recipient, typically cadaver bone from a bone bank where donor bone is typically disinfected and stored after stabilization by rapid freezing and dehydration under vacuum conditions (i.e., lyophilization). The bone is permanently implanted during plastic (reconstructive/augmentation) surgeries to provide body mass and structural/mechanical support.
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 00810017915828 SABER-XA, Simultaneous Expander ELEVATION SPINE, INC. HWB 2026-09-21 00810017915804 SABER-XA, Height Expander ELEVATION SPINE, INC. HWB 2026-08-14 00810017915811 SABER-XA, Lordosis Expander ELEVATION SPINE, INC. HWB 2026-08-14 00810017915958 Slap Hammer ELEVATION SPINE, INC. HWB 2026-08-14 00810017915965 Slap Hammer Adaptor ELEVATION SPINE, INC. HWB 2026-08-14 03701089527965 AMPLITUDE AMPLITUDE SAS HWB 2026-07-29 03701089527972 AMPLITUDE AMPLITUDE SAS HWB 2026-07-29 03701089531276 AMPLITUDE AMPLITUDE SAS HWB 2026-07-29 00889024711495 Z1 Extractor Zimmer, Inc. HWB 2026-07-20 08800068946966 BENCOX Corentec Co., Ltd HWB 2026-07-01 08800068946973 BENCOX Corentec Co., Ltd HWB 2026-07-01 08800068963666 BENCOX Corentec Co., Ltd HWB 2026-07-01 08806373897344 BENCOX Corentec Co., Ltd HWB 2026-07-01 08806373897351 BENCOX Corentec Co., Ltd HWB 2026-07-01 08806373897368 BENCOX Corentec Co., Ltd HWB 2026-07-01 08806373897375 BENCOX Corentec Co., Ltd HWB 2026-07-01 08806373897382 BENCOX Corentec Co., Ltd HWB 2026-07-01 10603295543695 ATTUNE DEPUY (IRELAND) HWB 2025-10-31 00810135963411 Impact NVision Biomedical Technologies, Inc. HWB 2025-09-24 00840314269737 gSource GSOURCE LLC HWB 2025-05-05 00885556820964 General Instruments Smith & Nephew, Inc. HWB 2023-10-27 00818069011031 Tecomet TECOMET INC. HWB 2023-08-10 00818069011048 Tecomet TECOMET INC. HWB 2023-08-10 00818069011055 Tecomet TECOMET INC. HWB 2023-08-10 00818069011062 Tecomet TECOMET INC. HWB 2023-08-10 00818069011079 Tecomet TECOMET INC. HWB 2023-08-10 00818069011086 Tecomet TECOMET INC. HWB 2023-08-10 00818069011093 Tecomet TECOMET INC. HWB 2023-08-10 00818069011109 Tecomet TECOMET INC. HWB 2023-08-10 00818069011116 Tecomet TECOMET INC. HWB 2023-08-10
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