FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
MONTAGE Settable, Resorbable Hemostatic Bone Putty
K Number: K152005
·
Decision Oct 15, 2015
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
41
Applicant Total
36
Review Days
87
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
- MONTAGE Settable, Resorbable Hemostatic Bone Putty
- K Number
- K152005
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthocon, Inc.
- Date Received
- July 20, 2015
- Decision Date
- October 15, 2015
- 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.
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
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
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 |