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FDA 510(k)

TSY SHOULDER PLATE IMPLANT

K-Number: K040850 · 2004-06-24

ApplicantOrthopedic Sciences, Inc.
Decision Date2004-06-24
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TSY SHOULDER PLATE IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Sciences, Inc.. It received FDA 510(k) clearance on 2004-06-24 under 510(k) number K040850. 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 TSY SHOULDER PLATE IMPLANT?

TSY SHOULDER PLATE IMPLANT is a medical device that received FDA 510(k) clearance on 2004-06-24. The listed applicant is Orthopedic Sciences, Inc.. The 510(k) number is K040850.

When did TSY SHOULDER PLATE IMPLANT receive FDA 510(k) clearance?

TSY SHOULDER PLATE IMPLANT received FDA 510(k) clearance on 2004-06-24, under 510(k) number K040850.

Who is the listed applicant for TSY SHOULDER PLATE IMPLANT?

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

What is the FDA product code for TSY SHOULDER PLATE IMPLANT?

The FDA product code for TSY SHOULDER PLATE IMPLANT is HRS.

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Other records listing Orthopedic Sciences, Inc. 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.

K091398ARTHROSCOPEK072175TITANIUM HIP TOOL LOCKING PLATEK063709TS-BONE HIP TOOLK063033MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANTK052538S-BONE HIP TOOLK051032TITANIUM-HIP TOOL

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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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