DeviceClearance

OSTEOTEC SILICONE FINGER IMPLANT— 510(k) K140453

Substantially Equivalent

Osteotec, Ltd.

FDA 510(k) clearance K140453 for OSTEOTEC SILICONE FINGER IMPLANT, Substantially Equivalent on 2015-04-17. Applicant: Osteotec, Ltd.. Device class: 2.

Clearance details

Applicant
Osteotec, Ltd.
Product code
Code KYJ
Device class
Class 2
Regulation
21 CFR 888.3230
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Christchurch, Dorset, GB
Download summary PDFView on FDA.gov ↗

Recent devices under product code KYJ

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Adverse events under product code KYJ

product code KYJ
Injury
210
Total
210

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 K140453

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 K140453.

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