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FDA 510(k)

ORTHOCOR KNEE SYSTEM BASIC

K-Number: K091996 · 2009-12-15

ApplicantOrthocor Medical
Decision Date2009-12-15
Product CodeILX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ORTHOCOR KNEE SYSTEM BASIC is the device name listed in this FDA 510(k) record. The listed applicant is Orthocor Medical. It received FDA 510(k) clearance on 2009-12-15 under 510(k) number K091996. 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 BASIC?

ORTHOCOR KNEE SYSTEM BASIC is a medical device that received FDA 510(k) clearance on 2009-12-15. The listed applicant is Orthocor Medical. The 510(k) number is K091996.

When did ORTHOCOR KNEE SYSTEM BASIC receive FDA 510(k) clearance?

ORTHOCOR KNEE SYSTEM BASIC received FDA 510(k) clearance on 2009-12-15, under 510(k) number K091996.

Who is the listed applicant for ORTHOCOR KNEE SYSTEM BASIC?

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 BASIC?

The FDA product code for ORTHOCOR KNEE SYSTEM BASIC is ILX.

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.

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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 DEVICEK092044ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE

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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