ROP Resorbable Hemostasis Material— 510(k) K153095

Name: FDA 510(k) clearance K153095
Creator: U.S. Food and Drug Administration
Published: 2016-02-17

Substantially Equivalent

Resorbable Orthopedic Products, LLC

FDA 510(k) clearance K153095 for ROP Resorbable Hemostasis Material, Substantially Equivalent on 2016-02-17. Applicant: Resorbable Orthopedic Products, LLC. Device class: Unclassified.

Clearance details

Applicant: Resorbable Orthopedic Products, LLC
Product code: Code MTJ
Device class: Unclassified
Advisory panel: Unknown
Date received: 2015-10-26
Decision date: 2016-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Addison, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MTJ

view all

K262769 — Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)2026-09-03
K261439 — Permatage Flowable, Settable Hemostatic Bone Paste2026-06-03
K232998 — Montage- XT Settable, Resorbable Hemostatic Bone Putty2023-10-12
K213418 — MONTAGE Settable, Resorbable Hemostatic Bone Putty2023-08-30
K231386 — Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste2023-07-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.