APEX ARC HIP STEM— 510(k) K090845
Substantially EquivalentOmni Life Science, Inc.
FDA 510(k) clearance K090845 for APEX ARC HIP STEM, Substantially Equivalent on 2010-04-07. Applicant: Omni Life Science, Inc.. Device class: 2.
Clearance details
- Applicant
- Omni Life Science, Inc.
- Product code
- Code LZO
- Device class
- Class 2
- Regulation
- 21 CFR 888.3353
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raynham, MA, US
Recent devices under product code LZO
view allMore clearances from Omni Life Science, Inc.
view allAdverse events under product code LZO
product code LZO- Death
- 17
- Injury
- 12,942
- Malfunction
- 1,756
- Total
- 14,715
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K090845
K-number listed on FDA's recall record- Z-2064-2015 — Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. They are manufactured from titanium alloy. The stem has a proximal porous coating of titanium plasma spray under a coating of hydroxyapatite (HA)
- Z-2241-2014 — Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090845.
Data sourced from openFDA. This site is unofficial and independent of the FDA.