FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BSM- BONE SUBSTITUTE MATERIAL
K Number: K983009
·
Decision Nov 25, 1998
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
43
Applicant Total
18
Review Days
89
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Basic Information
- Device Name
- BSM- BONE SUBSTITUTE MATERIAL
- K Number
- K983009
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5300
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Etex Corp.
- Date Received
- August 28, 1998
- Decision Date
- November 25, 1998
- Product Code
- GXP
- 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 |
|---|---|---|---|
| GXP | Methyl Methacrylate For Cranioplasty | FDA class 2 | Neurology |
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Other Clearances by Etex Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K100883 | CARRIGEN | Dec 21, 2010 | Substantially Equivalent |
| K101557 | GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN | Jul 1, 2010 | Substantially Equivalent |
| K093447 | CARRIGEN | Feb 18, 2010 | Substantially Equivalent |
| K091729 | ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE | Dec 23, 2009 | Substantially Equivalent |
| K091607 | ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE | Nov 2, 2009 | Substantially Equivalent |
| K090855 | EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE | Sep 18, 2009 | Substantially Equivalent |
| K090310 | EQUIVABONE | Mar 24, 2009 | Substantially Equivalent |
| K090242 | GAMMA-BSM, BETA-BSM | Feb 20, 2009 | Substantially Equivalent |
| K080329 | CAP PLUS, EQUIVABONE, CAP/DBM | Apr 28, 2008 | Substantially Equivalent |
| K063050 | CAP PLUS | Nov 19, 2007 | Substantially Equivalent |