FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Permatage Flowable, Settable Bone Paste
K Number: K253732
·
Decision Mar 13, 2026
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
43
Applicant Total
36
Review Days
109
Basic Information
- Device Name
- Permatage Flowable, Settable Bone Paste
- K Number
- K253732
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5300
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthocon, Inc.
- Date Received
- November 24, 2025
- Decision Date
- March 13, 2026
- Product Code
- GXP
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GXP | Methyl Methacrylate For Cranioplasty | FDA class 2 | Neurology |
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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 |
| 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 |
| K232771 | Montage Flowable Settable, Resorbable Bone Paste | Feb 16, 2024 | Substantially Equivalent |