Home GUDID M97022003200000 DynaNail
Primary DI M97022003200000
Brand DynaNail
Company Medshape, Inc.
Model 2200-32-0000
Device description M6 CONNECTION SCREW, DynaNail 2.0
Published 2025-10-16
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true 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 M97022003200000 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Orthopaedic bone-fragment manipulator, single-use A hand-held manual surgical instrument designed to help position a fractured fragment of bone to achieve proper alignment (reduction). It is typically a long, thin, rigid rod made of high-grade stainless steel with a self-drilling/self-tapping screw thread at the distal end and a connector at the proximal end to attach an appropriate handle. The device is usually inserted transcutaneously to the fractured section of bone (e.g., through the skin and into a craniofacial fracture) and removed after positioning and fixation of the fracture. This is a single-use device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 601306413 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label 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 00810166522816 Expanding Innovations EXPANDING INNOVATIONS, INC. LXH 2026-05-27 00810166522823 Expanding Innovations EXPANDING INNOVATIONS, INC. LXH 2026-05-27 00810166522830 Expanding Innovations EXPANDING INNOVATIONS, INC. LXH 2026-05-27 00810166522847 Expanding Innovations EXPANDING INNOVATIONS, INC. LXH 2026-05-27 00810166522854 Expanding Innovations EXPANDING INNOVATIONS, INC. LXH 2026-05-27 00810166522861 Expanding Innovations EXPANDING INNOVATIONS, INC. LXH 2026-05-27 00810166522878 Expanding Innovations EXPANDING INNOVATIONS, INC. LXH 2026-05-27 00889929072424 Matrixx System NEXXT SPINE, LLC LXH 2026-05-27 07640187918809 Straight reamer handle MPS Micro Precision Systems AG LXH 2026-05-27 07613327007114 ES2 SPINAL SYSTEM Stryker Corporation LXH 2019-11-25 07613327007558 XIA 3 Stryker Corporation LXH 2019-11-25 07613327007565 XIA 3 Stryker Corporation LXH 2019-11-25 07613327114881 XIA 4.5 EVOLUTION Stryker Corporation LXH 2019-11-25 07613327121919 XIA 4.5 EVOLUTION Stryker Corporation LXH 2019-11-25 07613327126273 AVS Anchor-C Cervical Cage System Stryker Corporation LXH 2019-11-25 07613327142662 XIA 4.5 EVOLUTION Stryker Corporation LXH 2019-11-25 07613327142679 XIA 4.5 EVOLUTION Stryker Corporation LXH 2019-11-25 07613327177480 OASYS Stryker Corporation LXH 2019-11-25 07613327261752 DIAPASON Stryker Corporation LXH 2019-11-25 07613327261943 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327261950 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327261967 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327261974 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327261998 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327262001 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327262018 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327262025 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327262032 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327262049 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327262056 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25