International Medical Devices Database

Manufacturer Address
Atlas Spine, Inc., 1555 Jupiter Park Dr Ste 4, Jupiter FL 33458-8085
Manufacturer Parent Company (2017)
Atlas Spine Inc.
Source
USFDA
2 Events
- Recall of Device Recall Apelo Modular Screwdriver for Apelo Pedicle Screw System
- Recall of Device Recall Atlas Spine Torque Limiting Handle

2 devices in the database

Device Recall Apelo Modular Screwdriver for Apelo Pedicle Screw System

Model / Serial
PN# 70175-001 CAT#2006-41-0000 Lot # 00686
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
USA Distribution to the state of Florida only.
Product Description
Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine, Inc.***www.AtlasSpine.com*** 1555 Jupiter Park Drive #4***Jupiter, Florida 33458***561-741-1108***Tissue Sleeve***MFG Date: XX/XX/XXXX***Lot #: XXXX***Weldment***MFG Date: 03/23/2009***Sleeve Assembly***MFG Date: XX/XX/XXXX***Lot #: XXXX***Qty: 1 Rx Only***Non-Sterile. Sterilize Prior to Use*** Rev. A***. The Modular Screwdriver is used to insert modular pedicle screw implants which are part of the Apelo System.

Device Recall Atlas Spine Torque Limiting Handle

Model / Serial
Lots #: 8887, 000073, 000135, 00434, and 02518.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution to FL, MO, and WV.
Product Description
Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 || Used to rotate implant into position

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Atlas Spine, Inc.

2 devices in the database

Device Recall Apelo Modular Screwdriver for Apelo Pedicle Screw System

Device Recall Atlas Spine Torque Limiting Handle