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FDA 510(k)

GEMINUS FOSSA SPECIFIC PLATE SYSTEM

K-Number: K122310 · 2013-01-18

ApplicantSkeletal Dynamics, LLC
Decision Date2013-01-18
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GEMINUS FOSSA SPECIFIC PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Skeletal Dynamics, LLC. It received FDA 510(k) clearance on 2013-01-18 under 510(k) number K122310. 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 GEMINUS FOSSA SPECIFIC PLATE SYSTEM?

GEMINUS FOSSA SPECIFIC PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-01-18. The listed applicant is Skeletal Dynamics, LLC. The 510(k) number is K122310.

When did GEMINUS FOSSA SPECIFIC PLATE SYSTEM receive FDA 510(k) clearance?

GEMINUS FOSSA SPECIFIC PLATE SYSTEM received FDA 510(k) clearance on 2013-01-18, under 510(k) number K122310.

Who is the listed applicant for GEMINUS FOSSA SPECIFIC PLATE SYSTEM?

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

What is the FDA product code for GEMINUS FOSSA SPECIFIC PLATE SYSTEM?

The FDA product code for GEMINUS FOSSA SPECIFIC PLATE SYSTEM is HRS.

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Other records listing Skeletal Dynamics, LLC 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.

K182492Geminus Volar Distal Radius Plate SystemK180744Stablyx CMC Arthroplasty Implant SystemK172688Align Radial Head SystemK171590Distal Elbow Plating SystemK122737GEMINUS FOSSA SPECIFIC PLATE SYSTEMK111068STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5

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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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