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FDA 510(k)

OSTEOMED HAND FUSION SYSTEM

K-Number: K111419 · 2011-10-07

ApplicantOsteomed LP
Decision Date2011-10-07
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEOMED HAND FUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed LP. It received FDA 510(k) clearance on 2011-10-07 under 510(k) number K111419. 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 OSTEOMED HAND FUSION SYSTEM?

OSTEOMED HAND FUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2011-10-07. The listed applicant is Osteomed LP. The 510(k) number is K111419.

When did OSTEOMED HAND FUSION SYSTEM receive FDA 510(k) clearance?

OSTEOMED HAND FUSION SYSTEM received FDA 510(k) clearance on 2011-10-07, under 510(k) number K111419.

Who is the listed applicant for OSTEOMED HAND FUSION SYSTEM?

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

What is the FDA product code for OSTEOMED HAND FUSION SYSTEM?

The FDA product code for OSTEOMED HAND FUSION SYSTEM is HRS.

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Other records listing Osteomed LP 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.

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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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