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FDA 510(k)

CHECKMATE SMALL BONE FUSION SYSTEM

K-Number: K122334 · 2012-11-28

ApplicantArthrosurface, Inc.
Decision Date2012-11-28
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CHECKMATE SMALL BONE FUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Arthrosurface, Inc.. It received FDA 510(k) clearance on 2012-11-28 under 510(k) number K122334. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHECKMATE SMALL BONE FUSION SYSTEM?

CHECKMATE SMALL BONE FUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2012-11-28. The listed applicant is Arthrosurface, Inc.. The 510(k) number is K122334.

When did CHECKMATE SMALL BONE FUSION SYSTEM receive FDA 510(k) clearance?

CHECKMATE SMALL BONE FUSION SYSTEM received FDA 510(k) clearance on 2012-11-28, under 510(k) number K122334.

Who is the listed applicant for CHECKMATE SMALL BONE FUSION SYSTEM?

The FDA 510(k) record lists Arthrosurface, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHECKMATE SMALL BONE FUSION SYSTEM?

The FDA product code for CHECKMATE SMALL BONE FUSION SYSTEM is HRS.

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Other records listing Arthrosurface, Inc. as applicant

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K203375OVOMotion Reverse Shoulder Arthroplasty SystemK200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemK190261BOSS Toe Fixation SystemK181280Patello-Femoral Wave (Kahuna) Arthroplasty SystemK173964OVOMotion Shoulder Arthroplasty SystemK172383Arthrosurface Bone Screws

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Related Devices (Code: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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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