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TAC' Pin

by New Deal, S.A.

510(k) K993910

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK993910 Date1 Feb 2000ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JDW
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The TAC' Pin is an orthopedic fixation device classified under product code JDW, designed for internal fixation of bone fractures or bone reconstructions. It is intended for securing small bone fragments or stabilizing bone segments during surgical procedures, ensuring proper alignment and healing.

This device is supplied sterile and intended for single-use. It is regulated under the FDA 510(k) clearance pathway (K993910) as a Class II orthopedic instrument, approved for traditional review. No MRI safety information or reusable specifications are provided in the regulatory data.

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Questions

AI-generated answers, 19 Sep 2026

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

  • What types of bone procedures is the TAC' PIN specifically designed to assist with?

    The TAC' PIN is designed for internal fixation of bone fractures or bone reconstructions, particularly for securing small bone fragments or stabilizing bone segments during surgery. Its purpose is to ensure proper alignment and support during the healing process.

  • Is the TAC' PIN intended for reuse, or is it meant to be used only once?

    The TAC' PIN is explicitly labeled as intended for single-use only. It is supplied sterile, which aligns with its one-time surgical application to avoid contamination risks.

  • How is the TAC' PIN regulated by the FDA, and what does that mean for its use?

    The TAC' PIN is regulated under the FDA’s 510(k) clearance pathway (K993910) as a Class II orthopedic instrument, approved through traditional review. This means it has been deemed substantially equivalent to a legally marketed device and meets FDA standards for safety and effectiveness before being cleared for commercial distribution.

  • What should clinicians consider regarding storage or handling of the TAC' PIN before use?

    Since the TAC' PIN is supplied sterile and intended for single-use, clinicians should store it in its original packaging until immediately before use to maintain sterility. Avoid exposure to moisture, extreme temperatures, or contamination, as these could compromise its integrity.