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FDA 510(k)

APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)

K-Number: K082468 · 2009-02-18

ApplicantOmni Life Science, Inc.
Decision Date2009-02-18
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60) is the device name listed in this FDA 510(k) record. The listed applicant is Omni Life Science, Inc.. It received FDA 510(k) clearance on 2009-02-18 under 510(k) number K082468. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)?

APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60) is a medical device that received FDA 510(k) clearance on 2009-02-18. The listed applicant is Omni Life Science, Inc.. The 510(k) number is K082468.

When did APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60) receive FDA 510(k) clearance?

APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60) received FDA 510(k) clearance on 2009-02-18, under 510(k) number K082468.

Who is the listed applicant for APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)?

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

What is the FDA product code for APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)?

The FDA product code for APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60) is KWY.

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Other records listing Omni Life Science, Inc. as applicant

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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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