Skip to content

Kls Martin Quick Disc

by KLS-Martin L.P.

510(k) K062857

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 NumberK062857 Date22 Nov 2006ClearedStatusActive

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  • Withdrawn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
GXN
FDA applicant
KLS Martin L.P.
Device class
Class II
Regulation
21 CFR Part 882.5330
Advisory committee
Neurology
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 KLS-Martin Quick Disc is a preformed, non-alterable cranioplasty plate designed for cranial reconstruction. It is intended for use in the reattachment of cranial bone flaps following craniotomy procedures, as well as covering burr holes and securing cranial fractures. Constructed as a single-use, non-resorbable implant, it provides structural support to restore cranial integrity.

This device is supplied sterile and intended for surgical use in neurosurgical settings. It is classified as a Class II medical device under FDA regulations (510(k) clearance K062857) and adheres to the Plate, Cranioplasty, Preformed, Non-Alterable nomenclature. Available in multiple reference codes (e.g., 3000270450, 1032347), it is intended for one-time use per patient and must be stored in accordance with manufacturer guidelines to maintain sterility.

Other devices from KLS-Martin L.P.

See all devices from KLS-Martin L.P. →

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 is the KLS-Martin Quick Disc primarily used for in surgical settings?

    The KLS-Martin Quick Disc is designed specifically for cranial reconstruction after craniotomy procedures. It is used to reattach cranial bone flaps, cover burr holes, and secure cranial fractures, providing structural support to restore cranial integrity.

  • Is the KLS-Martin Quick Disc intended for reuse, or is it meant to be used only once per patient?

    The KLS-Martin Quick Disc is explicitly labeled as a single-use device. It is intended for one-time use per patient and should not be reused, as this could compromise patient safety and sterility.

  • How should the KLS-Martin Quick Disc be stored to maintain its sterility?

    The device is supplied sterile, so it must be stored according to the manufacturer’s guidelines to preserve sterility. While the exact storage instructions aren’t detailed here, typical sterile medical devices require protection from contamination, moisture, and physical damage.

  • What types of reference codes or part numbers are associated with the KLS-Martin Quick Disc?

    The KLS-Martin Quick Disc comes in multiple reference codes, including but not limited to: 3000270450, 1032347, 3007923096, 3009196021, and others listed in the regulatory data. These codes help identify specific sizes or variations within the product line.

  • Is the KLS-Martin Quick Disc preformed or customizable, and what does that mean for its use?

    The KLS-Martin Quick Disc is described as a *preformed* cranioplasty plate, meaning it is manufactured in fixed shapes and sizes rather than being altered or customized during surgery. This design ensures consistency and ease of use for reattaching cranial bone flaps or covering defects.