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FDA 510(k)

AOC BONE WAX

K-Number: K041363 · 2004-07-27

ApplicantCeremed , Inc.
Decision Date2004-07-27
Product CodeMTJ
DecisionSubstantially Equivalent

Device Summary

AOC BONE WAX is the device name listed in this FDA 510(k) record. The listed applicant is Ceremed , Inc.. It received FDA 510(k) clearance on 2004-07-27 under 510(k) number K041363. The device is classified under product code MTJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AOC BONE WAX?

AOC BONE WAX is a medical device that received FDA 510(k) clearance on 2004-07-27. The listed applicant is Ceremed , Inc.. The 510(k) number is K041363.

When did AOC BONE WAX receive FDA 510(k) clearance?

AOC BONE WAX received FDA 510(k) clearance on 2004-07-27, under 510(k) number K041363.

Who is the listed applicant for AOC BONE WAX?

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?

The FDA product code for AOC BONE WAX is MTJ.

Other records listing Ceremed , Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: MTJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262769Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)Orthocon, Inc.K261439Permatage Flowable, Settable Hemostatic Bone PasteOrthocon, Inc.K232998Montage- XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.K213418MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.K231386Montage Flowable XRO Settable, Resorbable Hemostatic Bone PasteOrthocon, Inc.K200452Meril-BonewaxM/s. Meril Endo Surgery Private Limited.

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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