DeviceClearance

Restoration Anatomic Shell— 510(k) K151264

Substantially Equivalent

Stryker Orthopaedics

FDA 510(k) clearance K151264 for Restoration Anatomic Shell, Substantially Equivalent on 2015-08-10. 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
Download summary PDFView on FDA.gov ↗

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More clearances from Stryker Orthopaedics

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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, 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 K151264

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151264.

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