FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADAPTAIN SOLUBLE IMPLANT MATERIAL
K Number: K120220
·
Decision Jun 6, 2012
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
32
Applicant Total
20
Review Days
133
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Basic Information
- Device Name
- ADAPTAIN SOLUBLE IMPLANT MATERIAL
- K Number
- K120220
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3620
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ceremed , Inc.
- Date Received
- January 25, 2012
- Decision Date
- June 6, 2012
- Product Code
- KHJ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KHJ), ordered by most recent decision date.
Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)
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Biodesign Otologic Repair Graft
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Biodesign Otologic Repair Graft
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ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI
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BIODESIGN ENT REPAIR GRAFT
FDA 510(k)
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·Ear, Nose, Throat
ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
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 |
| 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 |