DeviceClearance

TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870— 510(k) K041595

Substantially Equivalent

Biopro, Inc.

FDA 510(k) clearance K041595 for TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870, Substantially Equivalent on 2004-11-12. Applicant: Biopro, Inc.. Device class: 2.

Clearance details

Applicant
Biopro, Inc.
Product code
Code KWD
Device class
Class 2
Regulation
21 CFR 888.3730
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Port Huron, MI, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KWD

product code KWD
Injury
164
Total
164

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 K041595

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 K041595.

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