Tilghman Titanium Mesh Skeletal Orbit Liner

FDA 510(k) K922308 · Ti-Mesh, Inc.

Substantially Equivalent

510(k) numberK922308

Submission

Device name
Tilghman Titanium Mesh Skeletal Orbit Liner
Applicant
Ti-Mesh, Inc.
Las Vegas, NV, US
Received
May 15, 1992
Decision date
January 12, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FTM – Mesh, Surgical
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3300
Specialty
General, Plastic Surgery
Implant
Yes

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Questions and answers

When was Tilghman Titanium Mesh Skeletal Orbit Liner cleared by the FDA?

Tilghman Titanium Mesh Skeletal Orbit Liner (K922308) received a 510(k) decision of Substantially Equivalent on January 12, 1993, 242 days after the submission was received.

What is the product code of K922308?

The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.