Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach— 510(k) K143085
Substantially EquivalentStryker Orthopaedics
FDA 510(k) clearance K143085 for Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach, Substantially Equivalent on 2015-02-09. Applicant: Stryker Orthopaedics. Device class: 2.
Clearance details
- Applicant
- Stryker Orthopaedics
- Product code
- Code LPH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3358
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mahwah, NJ, US
Recent devices under product code LPH
view allMore clearances from Stryker Orthopaedics
view allAdverse 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, 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 K143085
K-number listed on FDA's recall record- Z-0940-2018 — Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737
- Z-0941-2018 — Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535, 6021-0740, 6021-0230, and 6021-4535
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143085.
Data sourced from openFDA. This site is unofficial and independent of the FDA.