FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY
K Number: K061131
·
Decision Feb 8, 2007
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
30
Applicant Total
36
Review Days
290
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Basic Information
- Device Name
- DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY
- K Number
- K061131
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3045
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthocon, Inc.
- Date Received
- April 24, 2006
- Decision Date
- February 8, 2007
- 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 Orthocon, Inc.
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|---|---|---|---|
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| K253447 | Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) | Mar 16, 2026 | Substantially Equivalent |
| K253732 | Permatage Flowable, Settable Bone Paste | Mar 13, 2026 | Substantially Equivalent |
| K253854 | MONTAGE XT Cranial Cement | Jan 2, 2026 | Substantially Equivalent |
| K243526 | MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty | Dec 5, 2024 | Substantially Equivalent |
| K243506 | Montage-XT Settable Bone Putty | Nov 18, 2024 | Substantially Equivalent |
| K241027 | Permatage Settable Bone Putty | Sep 26, 2024 | Substantially Equivalent |
| K233566 | Montage-XT Settable, Resorbable Bone Putty | Aug 21, 2024 | Substantially Equivalent |
| K242050 | Montage Settable Bone Putty | Jul 29, 2024 | Substantially Equivalent |