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Dynanail Helix 3100-13-0001

by Medshape, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 27 Oct 2026. What this means

Regulatory status

as of registry sync 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00190446960300 UDI-DI Date9 Oct 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Dynanail Helix
Generic Name
Orthopaedic bone-fragment manipulator, single-use
Model / Reference
3100-13-0001
Primary DI / UDI-DI
00190446960300
FDA Product Code
LXH
GMDN Term
Orthopaedic bone-fragment manipulator, single-use
Device Class
Class I
Regulation Number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Overview

AI-generated summary, 27 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The device is an Orthopedic Manual Surgical Instrument, specifically a Orthopaedic bone-fragment manipulator, single-use. It is a hand-held manual surgical instrument designed to help position a fractured fragment of bone to achieve proper alignment (reduction). The instrument is 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. It is typically inserted transcutaneously to the fractured section of bone and removed after positioning and fixation of the fracture. This device is intended for single use only.

The device is classified as Class I, carries the product code LXH, and is regulated under 888.4540. It is currently in commercial distribution.

Other devices from Medshape, Inc.

See all devices from Medshape, Inc. →

Questions

AI-generated answers, 27 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Dynanail Helix 3100-13-0001?

    It is recorded under the device type "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. FDA lists it under the product name "Orthopedic Manual Surgical Instrument". It is recorded as Class I.

  • What are the product code and regulation of the Dynanail Helix 3100-13-0001?

    FDA records the Dynanail Helix 3100-13-0001 under product code LXH and regulation number 888.4540.

  • Who makes the Dynanail Helix 3100-13-0001?

    Medshape, Inc. is the manufacturer on record for the Dynanail Helix 3100-13-0001.

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No