CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM
FDA 510(k) clearance K010352 · decided 2001-03-14
Clearance details
- K-number
- K010352
- Device name
- CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM
- Applicant
- Inion , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2001-02-06
- Decision date
- 2001-03-14
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- JEY
- Device class
- 2
- Regulation number
- 872.4760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Tampere, FI
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 1.5 mm Inion CPS Baby, 4 hole plate, REF PLT-1000, sterile, Manufacturer, INION Oy, Finlan recall (Z-0630-2011) | Stryker Craniomaxillofacial Division | 2010-12-16 |
| 1.5 mm Inion CPS Baby , 20 hole plate, REF PLT-1001, sterile, Manufacturer, INION Oy, Finl recall (Z-0631-2011) | Stryker Craniomaxillofacial Division | 2010-12-16 |
| Inion 1.5 x 6mm CPS(R) Baby Screw, 1.5mm Inion CPS(R) Baby 5+E, REF SCR 1221, 5/pack, STER recall (Z-1550-2010) | Stryker Craniomaxillofacial Division | 2010-05-07 |