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TSRH Sacral Spinal Screw

by Warsaw Orthopedic, Inc.

510(k) K883783

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)SN Traditional NumberK883783 Date6 Apr 1989DecidedStatusActive

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  • Withdrawn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
KWP
Device Class
Class II
Regulation
21 CFR Part 888.3050
Advisory Committee
Orthopedic
FDA Decision
SN

Overview

AI-generated summary, 1 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 TSRH Sacral Spinal Screw is an orthopedic fixation device designed for spinal stabilization. It is classified as a spinal screw intended for use in sacral fixation procedures, providing mechanical support to the spine through bone engagement.

This device is supplied sterile and intended for single-use in surgical settings. It is regulated under FDA 510(k) clearance (K883783) with a product code KWP, falling under the orthopedic advisory committee classification. No third-party reprocessing is authorized, and MRI safety considerations must be reviewed per manufacturer guidelines.

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Questions

AI-generated answers, 1 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 TSRH Sacral Spinal Screw used for?

    The TSRH Sacral Spinal Screw is designed specifically for spinal stabilization in sacral fixation procedures. It provides mechanical support to the spine by engaging the sacral bone, helping to maintain alignment and structural integrity during surgical interventions.

  • Is the TSRH Sacral Spinal Screw sterile and single-use?

    Yes, the TSRH Sacral Spinal Screw is supplied sterile and intended for single-use only in surgical settings. This ensures patient safety and prevents cross-contamination, as no third-party reprocessing is authorized by the manufacturer.

  • What regulatory clearance does the TSRH Sacral Spinal Screw hold?

    The TSRH Sacral Spinal Screw holds FDA 510(k) clearance under the reference number K883783. It is classified under the product code KWP and falls under the orthopedic advisory committee classification, indicating it is substantially equivalent for some indications.

  • Are there any special considerations for MRI safety with this device?

    MRI safety considerations must be reviewed per the manufacturer’s guidelines before use. While the device itself is not explicitly labeled as MRI-safe or unsafe in the provided data, it is critical to consult the manufacturer’s instructions to ensure compatibility with MRI environments.

  • How is the TSRH Sacral Spinal Screw supplied?

    The TSRH Sacral Spinal Screw is supplied sterile and packaged for single-use surgical procedures. The packaging ensures sterility is maintained until the time of use, preventing contamination and ensuring optimal surgical conditions.