MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL— 510(k) K952677
Substantially EquivalentPorex Surgical, Inc.
FDA 510(k) clearance K952677 for MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL, Substantially Equivalent on 1995-08-21. Applicant: Porex Surgical, Inc.. Device class: 2.
Clearance details
- Applicant
- Porex Surgical, Inc.
- Product code
- Code FWP
- Device class
- Class 2
- Regulation
- 21 CFR 878.3550
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- College Park, GA, US
Recent devices under product code FWP
view allMore clearances from Porex Surgical, Inc.
view allRecalls naming K952677
K-number listed on FDA's recall record- Z-1091-2015 — MEDPOR BARRIER Sheets Orbital Floor Implant 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.
- Z-1092-2015 — MEDPOR BARRIER Sheets Rectangle 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 K952677.
Data sourced from openFDA. This site is unofficial and independent of the FDA.