ENDOBON— 510(k) K980679

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K980679 for ENDOBON, Substantially Equivalent on 1998-04-03. Applicant: Biomet, Inc.. Device class: 2.

Clearance details

Applicant: Biomet, Inc.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 1998-02-20
Decision date: 1998-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K980679

K-number listed on FDA's recall record

Z-1233-2014 — ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from ceramised bone for implantation or transplantation when bone is lost due to trauma or requested during reconstructive surgery.Class III·Terminated·Biomet 3i, LLC·20131003

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K980679.

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