Apex Hip System Bipolar Head (H3-822xx +3 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K082468

Identifiers

510(k) Number: K082468 FDA 510(k)
FDA Product Code: KWY FDA 510(k)
Models / Variants: H3-822xx FDA 510(k)
H3-828yy FDA 510(k)
Xx=od In [mm] (38-43) FDA 510(k)
Yy=od In [mm](44-60) FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 888.3390 FDA 510(k)
Regulation Number: 888.3390 FDA 510(k)
Advisory Committee: Orthopedic FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Apex Hip System Bipolar Head (H3-822xx +3 more) by OMNIlife science, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 4 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K082468	Class II	Active

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Manufacturer

Manufacturer: OMNIlife science, Inc.
FDA Applicant: Omni Life Science, Inc.

Sources (1)

FDA 510(k) K082468 24 fields · synced Jun 18, 2026