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FDA 510(k)

HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY

K-Number: K113627 · 2012-02-17

ApplicantOrthocon
Decision Date2012-02-17
Product CodeMTJ
DecisionSubstantially Equivalent

Device Summary

HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY is the device name listed in this FDA 510(k) record. The listed applicant is Orthocon. It received FDA 510(k) clearance on 2012-02-17 under 510(k) number K113627. The device is classified under product code MTJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY?

HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY is a medical device that received FDA 510(k) clearance on 2012-02-17. The listed applicant is Orthocon. The 510(k) number is K113627.

When did HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY receive FDA 510(k) clearance?

HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY received FDA 510(k) clearance on 2012-02-17, under 510(k) number K113627.

Who is the listed applicant for HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY?

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

What is the FDA product code for HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY?

The FDA product code for HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY is MTJ.

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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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