DeviceClearance

COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG)— 510(k) K062998

Substantially Equivalent

Biomet Manufacturing Corp

FDA 510(k) clearance K062998 for COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG), Substantially Equivalent on 2007-01-19. Applicant: Biomet Manufacturing Corp. Device class: 3.

Clearance details

Applicant
Biomet Manufacturing Corp
Product code
Code KWA
Device class
Class 3
Regulation
21 CFR 888.3330
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Warsaw, IN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KWA

product code KWA
Death
38
Injury
10,439
Malfunction
1,862
Total
12,339

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 K062998

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 K062998.

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