510(k) K251472
- Device
- Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System
- Applicant
- Inion OY
- 510(k) number
- K251472
- Product code
- HBW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-07-11
- Date received
- 2025-05-13
- Regulation
- 882.5360
- Classification name
- Fastener, Plate, Cranioplasty
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Hanne Kankaanpää
- Address
- Lääkärinkatu 2 Tampere FI FI-33520 FI-33520
FDA Registration Numbers
- 3016816754
- 1221485
- 3004719693
- 3004464325
- 2027148
- 1032347
- 8043792
- 2024024
- 2531195
- 3011530718
- 1000606483
- 1057946
- 3008812560
- 3003477135
- 3004049923
- 2916714
- 3002807310
- 1054811
- 8030965
- 3000270450
- 3007738812
- 3009417901
- 9610921
- 8010177
- 3006017180
- 1825034
- 3010155648
- 9610905
- 3008791302
- 3007923096
- 3017884860
- 3015399803
- 3008868758
- 3034676720
Source Documents
Other 510(k) Records For Product Code HBW
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231208 | Stryker Resorbable Fixation System | Stryker Leibinger GmbH & Co KG | 2023-08-14 |
| K171152 | Stryker Universal Neuro III System AXS Screw | Stryker | 2017-05-19 |
| K151387 | Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade | Stryker | 2015-06-24 |
| K141385 | DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) | Depuy Synthes Companies of Johnson & Johnson | 2015-03-27 |
| K101835 | MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 | Porex Surgical, Inc. | 2010-12-03 |
| K001353 | MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM | Biomedical Ent., Inc. | 2001-03-13 |