DeviceClearance

SHAPEMATCH CUTTING GUIDE— 510(k) K122053

Substantially Equivalent

Stryker Corp.

FDA 510(k) clearance K122053 for SHAPEMATCH CUTTING GUIDE, Substantially Equivalent on 2012-10-24. Applicant: Stryker Corp.. Device class: 2.

Clearance details

Applicant
Stryker Corp.
Product code
Code MBH
Device class
Class 2
Regulation
21 CFR 888.3565
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Alameda, CA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code MBH

view all

More clearances from Stryker Corp.

view all

Adverse events under product code MBH

product code MBH
Injury
6,545
Malfunction
2,023
Total
8,568

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 K122053

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 K122053.

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