Medpor Craniofacial Implants with Embedded Titanium Mesh
FDA 510(k) K040364 · Porex Surgical, Inc.
510(k) numberK040364
Submission
- Device name
- Medpor Craniofacial Implants with Embedded Titanium Mesh
- Applicant
- Porex Surgical, Inc.
Newnan, GA, US - Received
- February 13, 2004
- Decision date
- June 30, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 Medpor Craniofacial Implants with Embedded Titanium Mesh cleared by the FDA?
Medpor Craniofacial Implants with Embedded Titanium Mesh (K040364) received a 510(k) decision of Substantially Equivalent on June 30, 2004, 138 days after the submission was received.
What is the product code of K040364?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.