TnR Cranial Implant
FDA 510(k) clearance K251959 · decided 2026-07-30
Clearance details
- K-number
- K251959
- Device name
- TnR Cranial Implant
- Applicant
- T&R BIOFAB CO., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-06-26
- Decision date
- 2026-07-30
- Days to decision
- 399 days
- Clearance type
- Traditional
- Product code
- GXP
- Device class
- 2
- Regulation number
- 882.5300
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Gyeonggi-Do, KR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Permatage XT Settable Bone Putty (K261265) | Orthocon, Inc. | 2026-06-15 |
| Permatage Flowable, Settable Bone Paste (K253732) | Orthocon, Inc. | 2026-03-13 |
| MONTAGE XT Cranial Cement (K253854) | Orthocon, Inc. | 2026-01-02 |
| Permatage Settable Bone Putty (K241027) | Orthocon, Inc. | 2024-09-26 |
| Montage Flowable Settable, Resorbable Bone Paste (K232771) | Orthocon, Inc. | 2024-02-16 |
| MONTAGE-QS Settable, Resorbable Bone Putty (K231475) | Orthocon, Inc. | 2023-10-12 |
| MONTAGE Settable, Resorbable Bone Putty (K221933) | Orthocon, Inc. | 2023-01-13 |
| DB-CMF (K182742) | Dimensional Bioceramics, LLC | 2019-06-20 |
| OsteoVation Impact (K162864) | Skeletal Kinetics, LLC | 2017-01-13 |
| DirectInject (K143661) | Stryker | 2015-09-02 |
| NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY (K102018) | Synthes USA Products, LLC | 2010-09-23 |
| KRYPTONITE BONE CEMENT (K091382) | Doctors Research Group, Inc. | 2009-11-16 |
Recalls involving this device
No recalls on record reference this clearance.