DeviceClearance

BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS— 510(k) K001046

Substantially Equivalent

Biopro, Inc.

FDA 510(k) clearance K001046 for BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS, Substantially Equivalent on 2000-06-08. Applicant: Biopro, Inc..

Clearance details

Applicant
Biopro, Inc.
Product code
Code KWS
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Port Huron, MI, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KWS

product code KWS
Death
6
Injury
9,652
Malfunction
1,385
Other
1
Total
11,044

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 →

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