FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAP PLUS, EQUIVABONE, CAP/DBM
K Number: K080329
·
Decision Apr 28, 2008
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
30
Applicant Total
18
Review Days
81
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CAP PLUS, EQUIVABONE, CAP/DBM
- K Number
- K080329
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3045
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Etex Corp.
- Date Received
- February 7, 2008
- Decision Date
- April 28, 2008
- Product Code
- MBP
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MBP), ordered by most recent decision date.
PliaFX Flo
FDA 510(k)
FDA Class 2
·Orthopedic
Vivorte Trabexus EB
FDA 510(k)
FDA Class 2
·Orthopedic
VIVORTE BVF
FDA 510(k)
FDA Class 2
·Orthopedic
OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
FDA 510(k)
FDA Class 2
·Orthopedic
CLEARED UNDER GRAFTON II EDBM
FDA 510(k)
FDA Class 2
·Orthopedic
SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY
FDA 510(k)
FDA Class 2
·Orthopedic
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 |
| K063050 | CAP PLUS | Nov 19, 2007 | Substantially Equivalent |
| K072636 | A-BSM BONE SUBSTITUTE MATERIAL | Oct 23, 2007 | Substantially Equivalent |