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FDA 510(k)

OIC FLEX-FIX™ System

K-Number: K233531 · 2024-02-02

ApplicantOrthopaedic Implant Company
Decision Date2024-02-02
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OIC FLEX-FIX™ System is the device name listed in this FDA 510(k) record. The listed applicant is Orthopaedic Implant Company. It received FDA 510(k) clearance on 2024-02-02 under 510(k) number K233531. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OIC FLEX-FIX™ System?

OIC FLEX-FIX™ System is a medical device that received FDA 510(k) clearance on 2024-02-02. The listed applicant is Orthopaedic Implant Company. The 510(k) number is K233531.

When did OIC FLEX-FIX™ System receive FDA 510(k) clearance?

OIC FLEX-FIX™ System received FDA 510(k) clearance on 2024-02-02, under 510(k) number K233531.

Who is the listed applicant for OIC FLEX-FIX™ System?

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

What is the FDA product code for OIC FLEX-FIX™ System?

The FDA product code for OIC FLEX-FIX™ System is HTN.

Other records listing Orthopaedic Implant Company 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.

K223761OIC Intramedullary Screw SystemK223118OIC Variable Angle Small Fragment Locking Plate SystemK212601DRPx Locking Distal Radius Plate SystemK202971DRPx Locking Distal Radius Plate SystemK211112OIC External Fixation SystemK183682OIC External Fixation System

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Related Devices (Code: HTN)

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.

K253115LARS ACJMovmedix S.A.S.K252081SportLinc Syndesmosis DeviceLincotek MedicalK253727Syndesmosis TightRope PROArthrex, Inc.K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)K251134RipCordTriMed, Inc.K243624Acu-Sinch Knotless MiniAcumed, LLC

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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