Home GUDID M697N600015200
Spider Cervical Plating System
Primary DI M697N600015200
Brand Spider Cervical Plating System
Company Xtant Medical Holdings, Inc.
Model N60001520
Device description ASSEMBLY, SELF-CENTERING BONE AWL
Published 2015-09-04
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 true
Product Codes# Code, Name table Code Name HWJ AWL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HWJ Awl Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M697N600015200 Direct Marking HIBCC 0 M697N600015201 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Spinal fixation plate, non-bioabsorbable A small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and 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). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).
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 true 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 B8034609130 ORTHOMED ORTHO-MED, INC. HWJ 2026-07-16 B8034609140 ORTHOMED ORTHO-MED, INC. HWJ 2026-07-16 B8034609150 ORTHOMED ORTHO-MED, INC. HWJ 2026-07-16 B8034609160 ORTHOMED ORTHO-MED, INC. HWJ 2026-07-16 B8034803030 ORTHOMED ORTHO-MED, INC. HWJ 2026-07-16 B8034803360 ORTHOMED ORTHO-MED, INC. HWJ 2026-07-16 B8034803370 ORTHOMED ORTHO-MED, INC. HWJ 2026-07-16 B8034803380 ORTHOMED ORTHO-MED, INC. HWJ 2026-07-16 B8034803390 ORTHOMED ORTHO-MED, INC. HWJ 2026-07-16 B8034803400 ORTHOMED ORTHO-MED, INC. HWJ 2026-07-16 B8034803410 ORTHOMED ORTHO-MED, INC. HWJ 2026-07-16 00857915007767 IM Nail Awl A.M. SURGICAL, INC. HWJ 2026-06-10 00840311245376 Streamline MIS Spinal Fixation System Xtant Medical Holdings, Inc. HWJ 2026-04-30 08800322758137 Anyplus ll Spinal Fixation System GS Medical Co., Ltd. HWJ 2026-04-21 00860015151308 EnFix Instrument Kit - Complete TETROUS, INC. HWJ 2026-02-24 00887868287473 Trinica ALP Anterior Lumbar Plate System Highridge Medical, LLC HWJ 2025-11-12 07640375234773 SCARLET AL-T INSTRUMENTATION SpineArt SA HWJ 2025-11-10 08059386744338 Orthopaedic Surgical Instruments CITIEFFE SRL HWJ 2025-11-06 00763000674410 n/a MEDTRONIC SOFAMOR DANEK, INC. HWJ 2025-10-26 09120129291507 Awl, Curved, Cannulated I.T.S. GmbH HWJ 2025-10-21 09120129291514 Awl Trocar I.T.S. GmbH HWJ 2025-10-21 00763000878245 n/a MEDTRONIC SOFAMOR DANEK, INC. HWJ 2025-10-20 00840180541050 General Instruments ALPHATEC SPINE, INC. HWJ 2025-10-17 00763000885243 n/a MEDTRONIC SOFAMOR DANEK, INC. HWJ 2025-10-11 00816342025522 AWL PARCUS MEDICAL LLC HWJ 2025-09-16 00841732142329 GENERIC Surgical Instruments CTL Medical Corporation HWJ 2025-03-31 00841732142336 GENERIC Surgical Instruments CTL Medical Corporation HWJ 2025-03-31 00841732151642 GENERIC Surgical Instruments CTL Medical Corporation HWJ 2025-03-31 00841732151734 GENERIC Surgical Instruments CTL Medical Corporation HWJ 2025-03-31 00841732160330 GENERIC Surgical Instruments CTL Medical Corporation HWJ 2025-03-31