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FDA 510(k)

ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR

K-Number: K102762 · 2011-02-15

ApplicantOrthocon, Inc.
Decision Date2011-02-15
Product CodeMTJ
DecisionSubstantially Equivalent

Device Summary

ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Orthocon, Inc.. It received FDA 510(k) clearance on 2011-02-15 under 510(k) number K102762. The device is classified under product code MTJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR?

ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR is a medical device that received FDA 510(k) clearance on 2011-02-15. The listed applicant is Orthocon, Inc.. The 510(k) number is K102762.

When did ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR receive FDA 510(k) clearance?

ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR received FDA 510(k) clearance on 2011-02-15, under 510(k) number K102762.

Who is the listed applicant for ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR?

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 ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR?

The FDA product code for ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR is MTJ.

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Other records listing Orthocon, 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.

K262769Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)K261265Permatage XT Settable Bone PuttyK261439Permatage Flowable, Settable Hemostatic Bone PasteK253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)K253732Permatage Flowable, Settable Bone PasteK253854MONTAGE XT Cranial Cement

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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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