Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System
FDA 510(k) clearance K251472 · decided 2025-07-11
Clearance details
- K-number
- K251472
- Device name
- Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System
- Applicant
- Inion OY
- Decision
- Substantially Equivalent
- Date received
- 2025-05-13
- Decision date
- 2025-07-11
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- HBW
- Device class
- 2
- Regulation number
- 882.5360
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Tampere, FI
- 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 |
|---|---|---|
| Stryker Resorbable Fixation System (K231208) | Stryker Leibinger GmbH & Co KG | 2023-08-14 |
| Stryker Universal Neuro III System AXS Screw (K171152) | Stryker | 2017-05-19 |
| Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade (K151387) | Stryker | 2015-06-24 |
| DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) (K141385) | Depuy Synthes Companies of Johnson & Johnson | 2015-03-27 |
| MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 (K101835) | Porex Surgical, Inc. | 2010-12-03 |
| MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM (K001353) | Biomedical Ent., Inc. | 2001-03-13 |
Recalls involving this device
No recalls on record reference this clearance.