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FDA 510(k)

ROP Resorbable Hemostasis Material

K-Number: K153095 · 2016-02-17

ApplicantResorbable Orthopedic Products, LLC
Decision Date2016-02-17
Product CodeMTJ
DecisionSubstantially Equivalent

Device Summary

ROP Resorbable Hemostasis Material is the device name listed in this FDA 510(k) record. The listed applicant is Resorbable Orthopedic Products, LLC. It received FDA 510(k) clearance on 2016-02-17 under 510(k) number K153095. The device is classified under product code MTJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROP Resorbable Hemostasis Material?

ROP Resorbable Hemostasis Material is a medical device that received FDA 510(k) clearance on 2016-02-17. The listed applicant is Resorbable Orthopedic Products, LLC. The 510(k) number is K153095.

When did ROP Resorbable Hemostasis Material receive FDA 510(k) clearance?

ROP Resorbable Hemostasis Material received FDA 510(k) clearance on 2016-02-17, under 510(k) number K153095.

Who is the listed applicant for ROP Resorbable Hemostasis Material?

The FDA 510(k) record lists Resorbable Orthopedic Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROP Resorbable Hemostasis Material?

The FDA product code for ROP Resorbable Hemostasis Material is MTJ.

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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