FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste
K Number: K231386
·
Decision Jul 11, 2023
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
41
Applicant Total
36
Review Days
60
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Basic Information
- Device Name
- Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste
- K Number
- K231386
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthocon, Inc.
- Date Received
- May 12, 2023
- Decision Date
- July 11, 2023
- Product Code
- MTJ
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| MTJ | Wax, Bone | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MTJ), ordered by most recent decision date.
Permatage Flowable, Settable Hemostatic Bone Paste
FDA 510(k)
FDA Unclassified
·Unknown
Montage- XT Settable, Resorbable Hemostatic Bone Putty
FDA 510(k)
FDA Unclassified
·Unknown
MONTAGE Settable, Resorbable Hemostatic Bone Putty
FDA 510(k)
FDA Unclassified
·Unknown
Meril-Bonewax
FDA 510(k)
FDA Unclassified
·Unknown
MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty
FDA 510(k)
FDA Unclassified
·Unknown
HBP7 Settable Hemostatic Bone Putty
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Orthocon, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K261265 | Permatage XT Settable Bone Putty | Jun 15, 2026 | Substantially Equivalent |
| K261439 | Permatage Flowable, Settable Hemostatic Bone Paste | Jun 3, 2026 | Substantially Equivalent |
| 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 |