FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE
K Number: K072384
·
Decision Sep 21, 2007
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
491
Applicant Total
19
Review Days
28
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
- MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE
- K Number
- K072384
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3045
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kensey Nash Corp.
- Date Received
- August 24, 2007
- Decision Date
- September 21, 2007
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQV), ordered by most recent decision date.
Device 300419 Strip
FDA 510(k)
FDA Class 2
·Orthopedic
JAZBI Resorbable Bone Void Filler
FDA 510(k)
FDA Class 2
·Orthopedic
Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute
FDA 510(k)
FDA Class 2
·Orthopedic
Adaptos®Fuse Bone Graft
FDA 510(k)
FDA Class 2
·Orthopedic
FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute FIBERGRAFT BG Matrix Bone Graft Substitute
FDA 510(k)
FDA Class 2
·Orthopedic
Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Kensey Nash Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K103787 | MEDEOR MATRIX | Feb 7, 2011 | Substantially Equivalent |
| K091192 | KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX | Nov 2, 2009 | Substantially Equivalent |
| K091499 | MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) | Oct 22, 2009 | Substantially Equivalent |
| K090919 | KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE | Oct 2, 2009 | Substantially Equivalent |
| K073519 | QUICKCAT EXTRACTION CATHETER, MODEL 60090-01 | Mar 28, 2008 | Substantially Equivalent |
| K071695 | KENSEY NASH MACROPORE SHIELD | Dec 31, 2007 | Substantially Equivalent |
| K072195 | THROMCAT THROMBECTOMY CATHETER SYSTEM | Aug 23, 2007 | Substantially Equivalent |
| K071237 | COPIOS BONE VOID FILLER SPONGE AND PASTE | Jun 1, 2007 | Substantially Equivalent |
| K062870 | TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 | Oct 20, 2006 | Substantially Equivalent |
| K061772 | TRIACTIV FX EMBOLIC PROTECTION SYSTEM | Jul 11, 2006 | Substantially Equivalent |