Wrap, Implant, Orbital

FDA product code MTZ · Class II (moderate risk) · 21 CFR 886.3320 · Ophthalmic

2510(k) clearances
0PMA approvals
0recalls
Implantimplanted device

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K023643Macropore Surgical Barrier FilmMTZ · Traditional Macropore Biosurgery, Inc.02/21/2003SE
K973552Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant WrapMTZ · Traditional Bio-Vascular, Inc.12/16/1997SE