FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALLOCRAFT DBM
K Number: K052735
·
Decision Dec 28, 2005
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
30
Applicant Total
10
Review Days
89
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Basic Information
- Device Name
- ALLOCRAFT DBM
- K Number
- K052735
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3045
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lifecell Corp.
- Date Received
- September 30, 2005
- Decision Date
- December 28, 2005
- 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 |
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Other Clearances by Lifecell Corp.
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|---|---|---|---|
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| K121289 | LTM-LABAROSCOPIC SURGICAL MESH | Aug 3, 2012 | Substantially Equivalent |
| K082176 | LTM-BPS SURGICAL MESH | Nov 14, 2008 | Substantially Equivalent |
| K082103 | LTM WOUND DRESSING | Oct 8, 2008 | Substantially Equivalent |
| K080353 | LTM-T SURGICAL MESH | Apr 3, 2008 | Substantially Equivalent |
| K071986 | LTM-RC SURGICAL MESH | Oct 19, 2007 | Substantially Equivalent |
| K070560 | LRTM SURGICAL MESH | Jun 11, 2007 | Substantially Equivalent |
| K061208 | LIFECELL DURAL SUBSTITUTE MATRIX | Jan 3, 2007 | Substantially Equivalent |