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FDA 510(k)

HEMASORB APPLY

K-Number: K121953 · 2012-11-21

ApplicantOrthocon, Inc.
Decision Date2012-11-21
Product CodeMTJ
DecisionSubstantially Equivalent

Device Summary

HEMASORB APPLY is the device name listed in this FDA 510(k) record. The listed applicant is Orthocon, Inc.. It received FDA 510(k) clearance on 2012-11-21 under 510(k) number K121953. The device is classified under product code MTJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMASORB APPLY?

HEMASORB APPLY is a medical device that received FDA 510(k) clearance on 2012-11-21. The listed applicant is Orthocon, Inc.. The 510(k) number is K121953.

When did HEMASORB APPLY receive FDA 510(k) clearance?

HEMASORB APPLY received FDA 510(k) clearance on 2012-11-21, under 510(k) number K121953.

Who is the listed applicant for HEMASORB APPLY?

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

What is the FDA product code for HEMASORB APPLY?

The FDA product code for HEMASORB APPLY is MTJ.

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Other records listing Orthocon, Inc. as applicant

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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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