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FDA 510(k)

TWISTCUT ENDOSORB SCREWS

K-Number: K102777 · 2010-12-20

ApplicantMerete Medical GmbH
Decision Date2010-12-20
Product CodeJDW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TWISTCUT ENDOSORB SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Merete Medical GmbH. It received FDA 510(k) clearance on 2010-12-20 under 510(k) number K102777. The device is classified under product code JDW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TWISTCUT ENDOSORB SCREWS?

TWISTCUT ENDOSORB SCREWS is a medical device that received FDA 510(k) clearance on 2010-12-20. The listed applicant is Merete Medical GmbH. The 510(k) number is K102777.

When did TWISTCUT ENDOSORB SCREWS receive FDA 510(k) clearance?

TWISTCUT ENDOSORB SCREWS received FDA 510(k) clearance on 2010-12-20, under 510(k) number K102777.

Who is the listed applicant for TWISTCUT ENDOSORB SCREWS?

The FDA 510(k) record lists Merete Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TWISTCUT ENDOSORB SCREWS?

The FDA product code for TWISTCUT ENDOSORB SCREWS is JDW.

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Other records listing Merete Medical GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K160548MC-Subtalar(TM) IIK152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off ScrewsK132226METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHTK123619INTRABLOCK BIOBALL HIP SYSTEM (IBS)K130400MERETEC CS, CORTICAL SCREWSK120787MERETE LOCKING BONE PLATE SYSTEM III

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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