APEX HCLA ACETABULAR CUP LINERS— 510(k) K062489

Name: FDA 510(k) clearance K062489
Creator: U.S. Food and Drug Administration
Published: 2007-08-15

Substantially Equivalent

Omnilife Science

FDA 510(k) clearance K062489 for APEX HCLA ACETABULAR CUP LINERS, Substantially Equivalent on 2007-08-15. Applicant: Omnilife Science. Device class: 2.

Clearance details

Applicant: Omnilife Science
Product code: Code LPH
Device class: Class 2
Regulation: 21 CFR 888.3358
Advisory panel: Orthopedic
Date received: 2006-08-25
Decision date: 2007-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LPH

view all

K253630 — Mpact 3D Metal Foam2026-08-28
K254043 — TRIVANCE Hip Stem2026-08-04
K261624 — Omnifit® 20° Series I Insert +11 more2026-07-10
K243192 — iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating2026-06-05
K251270 — Taperloc® Complete Hip Stem2026-05-19

More clearances from Omnilife Science

view all

K201611 — Apex Knee System2021-04-02
K172467 — OMNI ARC Anteverted Neck Hip Stem2017-12-21
K171156 — OMNI Anseris Hip Stem2017-08-17
K163332 — Apex Revision Knee System2017-04-26
K153437 — Apex Revision Knee System2015-12-21

Adverse events under product code LPH

product code LPH

Death: 73
Injury: 31,640
Malfunction: 3,358
Other: 2
Total: 35,073

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.