USS Small Stature
Ref 498.462S, 498.021S, 498.483, 498.020S, 498.477S, 498.471S, 498.462, 498.472, 498.469, 498.037S, 498.470, 498.461, 498.464, 498.485, 498.461S, 498.469S, 498.478S, 498.485S, 498.022, 498.476, 498.484S, 498.303, 498.035, 498.036S, 498.022S, 498.463, 498.473S, 498.472S, 498.035S, 498.488, 498.487S, 498.484, 498.464S, 498.482, 498.021, 498.473, 498.487, 498.475Model USS for Spine Small Stature/Paediatric Pedicle Screw, USS for Spine Small Stature/Paediatric Fixing Component
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number7611819a00439JX | Date8 Aug 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Small Stature/Paediatric Pedicle ScrewSmall Stature/Paediatric Sleeve Nut Washer Connector Screw for Hook
- Model / Reference
- USS for Spine Small Stature/Paediatric Pedicle Screw, 498.462S, USS for Spine Small Stature/Paediatric Fixing Component, 498.021S, 498.483, 498.020S, 498.477S, 498.471S, 498.462, 498.472, 498.469, 498.037S, 498.470, 498.461, 498.464, 498.485, 498.461S, 498.469S, 498.478S, 498.485S, 498.022, 498.476, 498.484S, 498.303, 498.035, 498.036S, 498.022S, 498.463, 498.473S, 498.472S, 498.035S, 498.488, 498.487S, 498.484, 498.464S, 498.482, 498.021, 498.473, 498.487, 498.475
- Primary DI / UDI-DI
- 07611819966871, 07611819968127, 07611819114388, 07611819968110, 07611819968004, 07611819967953, 07611819114104, 07611819114296, 07611819114265, 07611819964501, 07611819114272, 07611819114098, 07611819114128, 07611819114401, 07611819966864, 07611819967939, 07611819968011, 07611819968073, 07611819717190, 07611819114326, 07611819968066, 07611819717923, 07611819717930, 07611819964495, 07611819968134, 07611819114111, 07611819967977, 07611819967960, 07611819964488, 07611819114432, 07611819968097, 07611819114395, 07611819966895, 07611819114371, 07611819717183, 07611819114302, 07611819114425, 07611819114319
- Basic UDI-DI
- 7611819a00439JX, 7611819a00440JG
- EMDN Code
- P09070302 Thoracolumbosacral fixation systems
- Device Class
- Class IIb
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- CH-MF-000013345
- Authorised representative
- DePuy Ireland UC IE-AR-000009328
Other devices from Synthes GmbH
Properties
Other properties (11)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No