FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
MONTAGE Settable, Resorbable Hemostatic Bone Putty
K Number: K213418
·
Decision Aug 30, 2023
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
40
Applicant Total
15
Review Days
679
Basic Information
- Device Name
- MONTAGE Settable, Resorbable Hemostatic Bone Putty
- K Number
- K213418
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthocon, Inc.
- Date Received
- October 20, 2021
- Decision Date
- August 30, 2023
- Product Code
- MTJ
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- 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.
Montage- XT Settable, Resorbable Hemostatic Bone Putty
FDA 510(k)
FDA Unclassified
·Unknown
Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste
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
HBP6 Settable, Resorbable Hemostatic Bone Paste
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Orthocon, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K241027 | Permatage Settable Bone Putty | Sep 26, 2024 | Substantially Equivalent |
| K233566 | Montage-XT Settable, Resorbable Bone Putty | Aug 21, 2024 | Substantially Equivalent |
| K232771 | Montage Flowable Settable, Resorbable Bone Paste | Feb 16, 2024 | Substantially Equivalent |
| K231475 | MONTAGE-QS Settable, Resorbable Bone Putty | Oct 12, 2023 | Substantially Equivalent |
| K232998 | Montage- XT Settable, Resorbable Hemostatic Bone Putty | Oct 12, 2023 | Substantially Equivalent |
| K231270 | Montage Flowable Settable, Resorbable Bone Paste | Sep 1, 2023 | Substantially Equivalent |
| K231903 | Montage-QS Settable, Resorbable Bone Putty | Aug 25, 2023 | Substantially Equivalent |
| K231386 | Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste | Jul 11, 2023 | Substantially Equivalent |
| K222063 | MONTAGE Settable, Resorbable Bone Putty | Feb 3, 2023 | Substantially Equivalent |
| K221933 | MONTAGE Settable, Resorbable Bone Putty | Jan 13, 2023 | Substantially Equivalent |