SUMMIT 174666055

GUDID 10705034022901

SUMMIT SI OCT SPINAL FIXATION SYSTEM DUAL WEDDING BAND ASSEMBLY 3.0/5.5mm

DEPUY SPINE, LLC

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10705034022901
• NIH Device Record Key: c9e9ac77-0e03-4d76-bc09-bb53de01874f
• Commercial Distribution Discontinuation: 2019-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SUMMIT
• Version Model Number: 174666055
• Catalog Number: 174666055
• Company DUNS: 107105876
• Company Name: DEPUY SPINE, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034022901 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013222

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10705034022901]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-12
• Device Publish Date: 2015-09-24

On-Brand Devices [SUMMIT]

• 10705034193106: SUMMIT FIXATION SYSTEM ANTI-CROSS THREAD DEVICE
• 10705034192949: SUMMIT SI OCT SPINAL FIXATION SYSTEM INSERTER
• 10705034192932: SUMMIT SI OCT SPINAL FIXATION SYSTEM PIN NUT INSERTER
• 10705034192727: SUMMIT FIXATION SYSTEM HEX DRIVER INSERTER 2.5mm
• 10705034022901: SUMMIT SI OCT SPINAL FIXATION SYSTEM DUAL WEDDING BAND ASSEMBLY 3.0/5.5mm
• 10705034022857: SUMMIT SI OCT SPINAL FIXATION SYSTEM DUAL DIAMETER ROD 3.0/ 5.5 X 600mm
• 10705034022789: SUMMIT SI OCT SPINAL FIXATION SYSTEM 3 HOLE INVERTED Y-PLATE 45mm
• 10705034022772: SUMMIT SI OCT SPINAL FIXATION SYSTEM 3 HOLE INVERTED Y-PLATE 37mm
• 10705034022765: SUMMIT SI OCT SPINAL FIXATION SYSTEM 3 HOLE INVERTED Y-PLATE 31mm
• 10705034022758: SUMMIT SI OCT SPINAL FIXATION SYSTEM OCCIPITAL INVERTED Y-PLATE 45mm
• 10705034022727: SUMMIT SI OCT SPINAL FIXATION SYSTEM OCCIPITAL T-PLATE 45mm
• 10705034022710: SUMMIT SI OCT SPINAL FIXATION SYSTEM OCCIPITAL T-PLATE 37mm
• 10705034022703: SUMMIT SI OCT SPINAL FIXATION SYSTEM OCCIPITAL T-PLATE 31mm
• 10705034022673: SUMMIT SI OCT SPINAL FIXATION SYSTEM OCCIPITAL T-PLATE 31mm
• 10705034022352: SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 4 x 50mm
• 10705034022031: SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 3.5 x 28mm
• 10705034021942: SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 3.5 x 10mm
• 10705034021928: SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 4 x 50mm
• 10705034021911: SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 4 x 48mm
• 10705034021713: SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 4 x 8mm
• 10705034021706: SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 3.5 x 50mm
• 10705034021638: SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 3.5 x 36mm
• 10705034021621: SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 3.5 x 34mm
• 10705034021607: SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 3.5 x 30mm
• 10705034021591: SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 3.5 x 28mm
• 10705034021508: SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3.0 x 3.5 x 10mm
• 10705034021119: SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3.0 x 3.5 x 50mm
• 10705034021102: SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3.0 x 3.5 x 48mm
• 10705034021096: SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3.0 x 3.5 x 46mm
• 10705034021089: SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3.0 x 3.5 x 44mm
• 10705034021072: SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3.0 x 3.5 x 42mm
• 10705034020679: SUMMIT BONE SCREWS BONE SCREW 3.5 x 10mm
• 10705034192666: SUMMIT FIXATION SYSTEM DRILL 2mm
• 10705034193564: SUMMIT SI OCT SPINAL FIXATION SYSTEM DEPTH GAUGE 6-50mm Plus or Minus 15 Percent
• 10705034193557: SUMMIT SI OCT SPINAL FIXATION SYSTEM OCCIPITAL BONE SCREW GAUGE
• 10705034193540: SUMMIT SI OCT SPINAL FIXATION SYSTEM FIXED DEPTH GUIDE 14/16mm
• 10705034193533: SUMMIT SI OCT SPINAL FIXATION SYSTEM FIXED DEPTH GUIDE 10/12mm
• 10705034193526: SUMMIT SI OCT SPINAL FIXATION SYSTEM FIXED DEPTH GUIDE 6/8mm
• 10705034193496: SUMMIT SI OCT SPINAL FIXATION SYSTEM TEMPLATE, DUAL DIAMETER ROD 420mm
• 10705034193489: SUMMIT SI OCT SPINAL FIXATION SYSTEM TEMPLATE, TRANSITION ROD 3/4/3mm
• 10705034193465: SUMMIT SI OCT SPINAL FIXATION SYSTEM X20 HEXLOBE DRIVER ASSEMBLY
• 10705034193458: SUMMIT SI OCT SPINAL FIXATION SYSTEM HEX DRIVER SHAFT 2.0mm
• 10705034193441: SUMMIT OCT SPINAL FIXATION SYSTEM TORQUE LIMITING DRIVER
• 10705034193427: SUMMIT OCT SPINAL FIXATION SYSTEM TEMPLATE, INVERTED-Y PLATE 37mm
• 10705034193410: SUMMIT OCT SPINAL FIXATION SYSTEM TEMPLATE, INVERTED-Y PLATE 31mm
• 10705034193373: SUMMIT SI OCT SPINAL FIXATION SYSTEM T-PLATE TEMPLATE 45mm
• 10705034193366: SUMMIT SI OCT SPINAL FIXATION SYSTEM T-PLATE TEMPLATE 37mm
• 10705034193304: SUMMIT SI OCT SPINAL FIXATION SYSTEM INSERTION SOCKET WRENCH
• 10705034193298: SUMMIT SI OCT SPINAL FIXATION SYSTEM NUT DRIVER
• 10705034193274: SUMMIT SI OCT SPINAL FIXATION SYSTEM HEX DRIVER, MINIMAL ACCESS 2.5mm