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FDA 510(k)

ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE

K-Number: K092044 · 2009-12-18

ApplicantOrthocor Medical
Decision Date2009-12-18
Product CodeILX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE is the device name listed in this FDA 510(k) record. The listed applicant is Orthocor Medical. It received FDA 510(k) clearance on 2009-12-18 under 510(k) number K092044. The device is classified under product code ILX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE?

ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE is a medical device that received FDA 510(k) clearance on 2009-12-18. The listed applicant is Orthocor Medical. The 510(k) number is K092044.

When did ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE receive FDA 510(k) clearance?

ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE received FDA 510(k) clearance on 2009-12-18, under 510(k) number K092044.

Who is the listed applicant for ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE?

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

What is the FDA product code for ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE?

The FDA product code for ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE is ILX.

Related Clinical Trials

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Other records listing Orthocor Medical 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.

K121702ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICEK091996ORTHOCOR KNEE SYSTEM BASIC

Related Devices (Code: ILX)

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.

K241395Active System; Avenue8Caerus CorporationK202337Pulsed electromagnetic field wrapHi-Dow International, Inc.K190251RecoveryRxBioelectronics CorporationK131979PROVANT THERAPY SYSTEMRegenesis Biomedical, Inc.K121702ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICEOrthocor MedicalK121338ZEOBIIvivi Health Science, LLC

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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