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SYNTHACER - Synthacer

by Medartis Medizinprodukte Und Forschung AG

510(k) K041177

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 NumberK041177 Date23 Jun 2005ClearedStatusActive

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  • Withdrawn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
MQV
Models / Variants
Synthacer
Device Class
Class II
Regulation
21 CFR Part 888.3045
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 Synthacer; Syntricer is a calcium salt bone void filler, classified under the FDA product code MQV in the orthopedic category. It is designed as a resorbable biomaterial intended to fill and support bone defects, promoting natural bone regeneration through its osteoconductive properties.

This device is supplied in sterile form for single-use applications in orthopedic surgical settings. It is regulated under FDA 510(k) clearance (K041177) as a Class II moderate-risk device, with specific versions or model numbers such as T672CB06-10-1 available. Storage and handling must comply with sterile medical device protocols to ensure integrity prior to use.

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 defects is the Synthacer; Syntricer designed to address in orthopedic procedures?

    The Synthacer; Syntricer is a calcium salt bone void filler intended to fill and support bone defects, particularly in orthopedic surgeries. Its osteoconductive properties help promote natural bone regeneration, making it suitable for filling gaps or cavities in bone structures where support is needed during healing.

  • Is the Synthacer; Syntricer meant for repeated use in the same patient, or is it single-use only?

    The Synthacer; Syntricer is explicitly supplied as a sterile, single-use device. It must not be reused after a single surgical application to maintain sterility and ensure patient safety, as outlined in its handling instructions.

  • How should the Synthacer; Syntricer be stored to preserve its sterility before use?

    Since the Synthacer; Syntricer is sterile and intended for single-use, it must be stored according to standard sterile medical device protocols. This includes keeping it in its original packaging, away from contamination, and adhering to manufacturer guidelines to ensure its integrity until the time of use.

  • What does the model number (e.g., T672CB06-10-1) indicate about the specific version of the Synthacer; Syntricer?

    The model number (such as T672CB06-10-1) identifies a specific version or variant of the Synthacer; Syntricer, likely differentiating it by size, composition, or other technical specifications. While the exact details of this model aren’t provided, such numbering is common in medical devices to ensure proper selection for surgical needs.