FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Biopor Porous Polyethylene Implants
K Number: K161446
·
Decision Sep 27, 2016
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
41
Applicant Total
20
Review Days
125
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Basic Information
- Device Name
- Biopor Porous Polyethylene Implants
- K Number
- K161446
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ceremed , Inc.
- Date Received
- May 25, 2016
- Decision Date
- September 27, 2016
- Product Code
- GWO
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GWO | Plate, Cranioplasty, Preformed, Alterable | FDA class 2 | Neurology |
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Other Clearances by Ceremed , Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K160988 | Biopor, AOC Porous Polyethylene, Cerepor | Jul 14, 2016 | Substantially Equivalent |
| K141880 | BIOPOR AOC POROUS POLYETHYLENE, CEREPOR | Apr 16, 2015 | Substantially Equivalent |
| K132198 | ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI | Sep 12, 2013 | Substantially Equivalent |
| K122561 | ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN | Nov 27, 2012 | Substantially Equivalent |
| K120220 | ADAPTAIN SOLUBLE IMPLANT MATERIAL | Jun 6, 2012 | Substantially Equivalent |
| K103047 | CERETENE SOLUBLE IMPLANT MATERIAL | Jan 5, 2011 | Substantially Equivalent |
| K102071 | OSTENE CT, AOC CT, OSTEOTENE, CERETENE | Oct 8, 2010 | Substantially Equivalent |
| K091636 | OSTENE CT, AOC CT, OSTEOTENE, CERETENE | Jun 22, 2009 | Substantially Equivalent |
| K082491 | OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTENE & CERETENE | Sep 24, 2008 | Substantially Equivalent |
| K082245 | AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV | Sep 18, 2008 | Substantially Equivalent |