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FDA 510(k)

HBP6 Settable, Resorbable Hemostatic Bone Paste

K-Number: K193052 · 2020-03-27

ApplicantOrthocon, Inc.
Decision Date2020-03-27
Product CodeMTJ
DecisionSubstantially Equivalent

Device Summary

HBP6 Settable, Resorbable Hemostatic Bone Paste is the device name listed in this FDA 510(k) record. The listed applicant is Orthocon, Inc.. It received FDA 510(k) clearance on 2020-03-27 under 510(k) number K193052. The device is classified under product code MTJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HBP6 Settable, Resorbable Hemostatic Bone Paste?

HBP6 Settable, Resorbable Hemostatic Bone Paste is a medical device that received FDA 510(k) clearance on 2020-03-27. The listed applicant is Orthocon, Inc.. The 510(k) number is K193052.

When did HBP6 Settable, Resorbable Hemostatic Bone Paste receive FDA 510(k) clearance?

HBP6 Settable, Resorbable Hemostatic Bone Paste received FDA 510(k) clearance on 2020-03-27, under 510(k) number K193052.

Who is the listed applicant for HBP6 Settable, Resorbable Hemostatic Bone Paste?

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 HBP6 Settable, Resorbable Hemostatic Bone Paste?

The FDA product code for HBP6 Settable, Resorbable Hemostatic Bone Paste is MTJ.

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.

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 CementK243526MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty

View all 24 devices →

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.

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.K220315MONTAGE-XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.

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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