MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH— 510(k) K040364
Substantially EquivalentPorex Surgical, Inc.
FDA 510(k) clearance K040364 for MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH, Substantially Equivalent on 2004-06-30. Applicant: Porex Surgical, Inc.. Device class: 2.
Clearance details
- Applicant
- Porex Surgical, Inc.
- Product code
- Code FTM
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newnan, GA, US
Recent devices under product code FTM
view allMore clearances from Porex Surgical, Inc.
view allAdverse events under product code FTM
product code FTM- Death
- 17
- Injury
- 2,174
- Total
- 2,191
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K040364
K-number listed on FDA's recall record- Z-0715-2022 — MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
- Z-1093-2015 — MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040364.
Data sourced from openFDA. This site is unofficial and independent of the FDA.