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FDA 510(k)

AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12

K-Number: K050440 · 2005-03-24

ApplicantCeremed , Inc.
Decision Date2005-03-24
Product CodeMTJ
DecisionSubstantially Equivalent

Device Summary

AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12 is the device name listed in this FDA 510(k) record. The listed applicant is Ceremed , Inc.. It received FDA 510(k) clearance on 2005-03-24 under 510(k) number K050440. The device is classified under product code MTJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12?

AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12 is a medical device that received FDA 510(k) clearance on 2005-03-24. The listed applicant is Ceremed , Inc.. The 510(k) number is K050440.

When did AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12 receive FDA 510(k) clearance?

AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12 received FDA 510(k) clearance on 2005-03-24, under 510(k) number K050440.

Who is the listed applicant for AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12?

The FDA 510(k) record lists Ceremed , Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12?

The FDA product code for AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12 is MTJ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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