FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BETA-TCP GRANULES
K Number: K120354
·
Decision Mar 21, 2013
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
491
Applicant Total
10
Review Days
409
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Basic Information
- Device Name
- BETA-TCP GRANULES
- K Number
- K120354
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3045
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Skeletal Kinetics, LLC
- Date Received
- February 6, 2012
- Decision Date
- March 21, 2013
- Product Code
- MQV
- 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 |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | FDA class 2 | Orthopedic |
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Other Clearances by Skeletal Kinetics, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K162864 | OsteoVation Impact | Jan 13, 2017 | Substantially Equivalent |
| K132211 | SKAFFOLD NMX BONE VOID FILLER | Aug 4, 2014 | Substantially Equivalent |
| K112383 | CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER | Feb 7, 2012 | Substantially Equivalent |
| K111538 | SKAFFOLD CIS | Oct 25, 2011 | Substantially Equivalent |
| K100986 | CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION | Jul 20, 2010 | Substantially Equivalent |
| K051784 | OSTEOVATION CMF BONE VOID FILLER | Jul 20, 2005 | Substantially Equivalent |
| K051123 | CALLOS IMPACT AND INJECT BONE VOID FILLER | Jun 3, 2005 | Substantially Equivalent |
| K042072 | CALLOS CMF BONE VOID FILLER | Sep 16, 2004 | Substantially Equivalent |
| K030554 | CALLOS | May 20, 2003 | Substantially Equivalent |