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FDA 510(k)

MODIFICATION TO: APEX KNEE SYSTEM

K-Number: K073602 · 2008-02-14

ApplicantOmnlife Science
Decision Date2008-02-14
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: APEX KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Omnlife Science. It received FDA 510(k) clearance on 2008-02-14 under 510(k) number K073602. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: APEX KNEE SYSTEM?

MODIFICATION TO: APEX KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2008-02-14. The listed applicant is Omnlife Science. The 510(k) number is K073602.

When did MODIFICATION TO: APEX KNEE SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO: APEX KNEE SYSTEM received FDA 510(k) clearance on 2008-02-14, under 510(k) number K073602.

Who is the listed applicant for MODIFICATION TO: APEX KNEE SYSTEM?

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

What is the FDA product code for MODIFICATION TO: APEX KNEE SYSTEM?

The FDA product code for MODIFICATION TO: APEX KNEE SYSTEM is JWH.

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 Omnlife Science 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.

K112779APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM)K101994APEX KNEE MODULAR TIBIA SYSTEMK101575APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010K100151APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM)

Related Devices (Code: JWH)

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.

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

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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