DeviceClearance

IMBIBE NEEDLE— 510(k) K140414

Substantially Equivalent

Orthovita, Inc.

FDA 510(k) clearance K140414 for IMBIBE NEEDLE, Substantially Equivalent on 2014-04-01. Applicant: Orthovita, Inc.. Device class: 1.

Clearance details

Applicant
Orthovita, Inc.
Product code
Code LXH
Device class
Class 1
Regulation
21 CFR 888.4540
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Malvern, PA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LXH

product code LXH
Death
11
Injury
2,218
Malfunction
31,318
Total
33,547

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 K140414

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 K140414.

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