DeviceClearance

ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSET— 510(k) K141821

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K141821 for ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSET, Substantially Equivalent on 2014-08-28. Applicant: Exactech, Inc.. Device class: 2.

Clearance details

Applicant
Exactech, Inc.
Product code
Code LZO
Device class
Class 2
Regulation
21 CFR 888.3353
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Gainesville, FL, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code LZO

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More clearances from Exactech, Inc.

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Adverse events under product code LZO

product code LZO
Death
17
Injury
12,942
Malfunction
1,756
Total
14,715

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 K141821

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 K141821.

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