FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
B-GENIN, R-GENIN
K Number: K113791
·
Decision Mar 15, 2012
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
491
Applicant Total
13
Review Days
84
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Basic Information
- Device Name
- B-GENIN, R-GENIN
- K Number
- K113791
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3045
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Berkeley Advanced Biomaterials, Inc.
- Date Received
- December 22, 2011
- Decision Date
- March 15, 2012
- 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 Berkeley Advanced Biomaterials, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K091912 | B-GENIN AND R-GENIN | Jun 23, 2010 | Substantially Equivalent |
| K092046 | BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY | Mar 24, 2010 | Substantially Equivalent |
| K053213 | BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM | Jul 6, 2006 | Substantially Equivalent |
| K051914 | GENEROS 80, GENEROS 60 | Nov 3, 2005 | Substantially Equivalent |
| K051695 | MARROW PLUS (M+) | Jul 19, 2005 | Substantially Equivalent |
| K050666 | GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES | Apr 11, 2005 | Substantially Equivalent |
| K042636 | BIOPLUS | Dec 14, 2004 | Substantially Equivalent |
| K041889 | TRI-OSTETIC | Aug 19, 2004 | Substantially Equivalent |
| K040405 | CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY | Mar 5, 2004 | Substantially Equivalent |
| K030266 | CEM-OSTETIC BONE; CEMO-10G, CEMO-20G, CEMO-30G, CEMO-40G, CEMO-60G, CEM0-XXGC; CEMO-XYZ202005P, CEMO-XYZ20210P, CEMO-XYZ | Feb 20, 2003 | Substantially Equivalent |