FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
OSTENE CT, AOC CT, OSTEOTENE, CERETENE
K Number: K102071
·
Decision Oct 8, 2010
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
41
Applicant Total
20
Review Days
77
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Basic Information
- Device Name
- OSTENE CT, AOC CT, OSTEOTENE, CERETENE
- K Number
- K102071
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ceremed , Inc.
- Date Received
- July 23, 2010
- Decision Date
- October 8, 2010
- Product Code
- MTJ
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| MTJ | Wax, Bone | FDA unclassified | Unknown |
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Other Clearances by Ceremed , Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K161446 | Biopor Porous Polyethylene Implants | Sep 27, 2016 | Substantially Equivalent |
| 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 |
| 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 |