Devices

3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM

Model / Serial
Part Number:. 00-0903-2634 and lot number 009U2
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution - US including Michigan and the countries of Ireland and Australia
Product Description
3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM || The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good rotational stability while maintaining bone stock. Cannulated instruments work over a guide wire for precise placement and safety. The subject device is a Bone Screw designed for use with this system.
Manufacturer
OrthoPediatrics Corp
1 Event
- Recall of 3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM

Manufacturer

OrthoPediatrics Corp

Manufacturer Address
OrthoPediatrics Corp, 2850 Frontier Dr, Warsaw IN 46582-7001
Manufacturer Parent Company (2017)
Orthopediatrics Corp
Source
USFDA

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