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FDA 510(k)

ORTHOFLEX ROD

K-Number: K102601 · 2011-01-14

ApplicantOrtho-Pro, LLC
Decision Date2011-01-14
Product CodeKWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOFLEX ROD is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Pro, LLC. It received FDA 510(k) clearance on 2011-01-14 under 510(k) number K102601. The device is classified under product code KWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOFLEX ROD?

ORTHOFLEX ROD is a medical device that received FDA 510(k) clearance on 2011-01-14. The listed applicant is Ortho-Pro, LLC. The 510(k) number is K102601.

When did ORTHOFLEX ROD receive FDA 510(k) clearance?

ORTHOFLEX ROD received FDA 510(k) clearance on 2011-01-14, under 510(k) number K102601.

Who is the listed applicant for ORTHOFLEX ROD?

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

What is the FDA product code for ORTHOFLEX ROD?

The FDA product code for ORTHOFLEX ROD is KWH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ortho-Pro, 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.

K094037TC PLATING SYSTEMK042310ORTHO-PRO CANNULATED BONE SCREWSK032682STS SCREW

Related Devices (Code: KWH)

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.

K191966NewPrim SystemBrm ExtremitiesK190136Fusion Silastic SystemFusion Orthopedics, LLCK173491RTS Lesser MTP Implant SystemIn2bones USA, LLCK153609RTS Flexible 1 MPJ Implant w/GrommetsIn2bones USA, LLCK023531LESSER METATARSAL PHALANGEAL JOINT IMPLANTNexa Orthopedics, Inc.K022887INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEMOsteomed Corp.

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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