Device class
Class II
Regulation 882.5300
Total clearances
8
2023-01-13 → 2026-07-30
Classification details
Medical specialty
Neurology
Regulation number
882.5300
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Orthocon, Inc.
|
7 |
3 |
2026-06-15 |
|
T&R BIOFAB CO., Ltd. |
1 |
1 |
2026-07-30 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 20670 |
CPT
|
— |
Medium
|
Cranioplasty with bone graft; methyl methacrylate is a common cranioplasty material component |
| A4649 |
HCPCS
|
Surgical supply; miscellaneous ✓ CMS-verified description |
Low
|
Surgical supplies; generic supply code for bone cement materials |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-07-30 |
K251959 |
T&R BIOFAB CO., Ltd.
|
TnR Cranial Implant |
| 2026-06-15 |
K261265 |
Orthocon, Inc.
|
Permatage XT Settable Bone Putty |
| 2026-03-13 |
K253732 |
Orthocon, Inc.
|
Permatage Flowable, Settable Bone Paste |
| 2026-01-02 |
K253854 |
Orthocon, Inc.
|
MONTAGE XT Cranial Cement |
| 2024-09-26 |
K241027 |
Orthocon, Inc.
|
Permatage Settable Bone Putty |
| 2024-02-16 |
K232771 |
Orthocon, Inc.
|
Montage Flowable Settable, Resorbable Bone Paste |
| 2023-10-12 |
K231475 |
Orthocon, Inc.
|
MONTAGE-QS Settable, Resorbable Bone Putty |
| 2023-01-13 |
K221933 |
Orthocon, Inc.
|
MONTAGE Settable, Resorbable Bone Putty |