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FDA 510(k)

OTI EUROPEAN COMPRESSION SYSTEM

K-Number: K925571 · 1993-07-13

ApplicantOsteo-Technology Intl., Inc.
Decision Date1993-07-13
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OTI EUROPEAN COMPRESSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteo-Technology Intl., Inc.. It received FDA 510(k) clearance on 1993-07-13 under 510(k) number K925571. 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 OTI EUROPEAN COMPRESSION SYSTEM?

OTI EUROPEAN COMPRESSION SYSTEM is a medical device that received FDA 510(k) clearance on 1993-07-13. The listed applicant is Osteo-Technology Intl., Inc.. The 510(k) number is K925571.

When did OTI EUROPEAN COMPRESSION SYSTEM receive FDA 510(k) clearance?

OTI EUROPEAN COMPRESSION SYSTEM received FDA 510(k) clearance on 1993-07-13, under 510(k) number K925571.

Who is the listed applicant for OTI EUROPEAN COMPRESSION SYSTEM?

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

What is the FDA product code for OTI EUROPEAN COMPRESSION SYSTEM?

The FDA product code for OTI EUROPEAN COMPRESSION SYSTEM is HRS.

Related Clinical Trials

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Other records listing Osteo-Technology Intl., 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.

K951741REPLICA TOTAL HIP SYSTEMK935012BIOMETRIC TOTAL HIP SYSTEM

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

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

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