ISOLA 50001538

GUDID 10705034011400

ISOLA SPINE SYSTEM EASY ROD 6.35 x 457.2mm

DEPUY SPINE, LLC

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10705034011400
• NIH Device Record Key: bfca2f49-7b79-4e3d-88de-0db52c01fb29
• Commercial Distribution Discontinuation: 2019-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISOLA
• Version Model Number: 50001538
• Catalog Number: 50001538
• 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	10705034011400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980485

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[10705034011400]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-12
• Device Publish Date: 2015-09-24

On-Brand Devices [ISOLA]

• 10705034243191: ISOLA SPINE SYSTEM OFFSET SLOTTED CONNECTOR 6.35mm
• 10705034243184: ISOLA SPINE SYSTEM ANGLED SLOTTED CONNECTOR 6.35mm
• 10705034003627: ISOLA SPINE SYSTEM STRAIGHT SLOTTED CONNECTOR 6.35mm
• 10705034003405: ISOLA SPINE SYSTEM EXTENDED SLOTTED CONNECTOR 6.35mm
• 10705034003399: ISOLA SPINE SYSTEM STRAIGHT SLOTTED CONNECTOR 6.35mm
• 10705034001630: ISOLA SPINE SYSTEM HOOK ROTATOR
• 10705034001524: ISOLA SPINE SYSTEM OPEN HOOK CAP REMOVER
• 10705034011295: ISOLA SPINE SYSTEM SPINAL ROD 4.75 x 457.2mm
• 10705034005782: ISOLA SPINE SYSTEM OPEN HOOK 4.75 x 9.5mm
• 10705034005737: ISOLA SPINE SYSTEM OPEN HOOK 4.75 x 8.0mm
• 10705034156460: ISOLA SPINE SYSTEM EXTENDED SLOTTED CONNECTOR 5.5mm
• 10705034012940: ISOLA SPINE SYSTEM SPINAL ROD 6.35 x 457.2mm
• 10705034012919: ISOLA SPINE SYSTEM SPINAL ROD 4.75 x 457.2mm
• 10705034011400: ISOLA SPINE SYSTEM EASY ROD 6.35 x 457.2mm
• 10705034011394: ISOLA SPINE SYSTEM SPINAL ROD 6.35 x 457.2mm
• 10705034011370: ISOLA SPINE SYSTEM SPINAL ROD 6.35 x 609.6mm
• 10705034005126: ISOLA SPINE SYSTEM MCC J-HOOK 6.35mm
• 10705034005119: ISOLA SPINE SYSTEM MCC PLATE 50-70mm
• 10705034005096: ISOLA SPINE SYSTEM MCC PLATE 30-50mm
• 10705034005072: ISOLA SPINE SYSTEM MCC PLATE 15-30mm
• 10705034005065: ISOLA SPINE SYSTEM MCC PLATE 10-25mm
• 10705034001456: ISOLA SYSTEM MINI HEXDRIVER 3.18mm
• 10705034001340: ISOLA SPINE SYSTEM GONIOMETER
• 10705034240718: ISOLA SPINE SYSTEM STRAIGHT ROD HOLDER 4.75mm
• 10705034004853: ISOLA SPINE SYSTEM BONE MARKER-DOUBLE BARREL
• 10705034004846: ISOLA SPINE SYSTEM BONE MARKER-SINGLE BARREL
• 10705034001722: ISOLA SPINE SYSTEM TOGGLE FREE HOOK HOLDER
• 10705034001715: ISOLA SPINE SYSTEM TOGGLE FREE HOOK HOLDER
• 10705034001685: ISOLA SPINE SYSTEM RING HANDLE ROD HOLDER 4.75mm
• 10705034001548: ISOLA SPINE SYSTEM OPEN HOOK HOLDER
• 10705034001425: ISOLA SPINE SYSTEM POWERGRIP ROD HOLDER 6.35mm
• 10705034001395: ISOLA SPINE SYSTEM SMALL STRAIGHT ROD HOLDER 4.75mm
• 10705034001371: ISOLA SPINE SYSTEM POWERGRIP ROD HOLDER 4.75mm
• 10705034001364: ISOLA SPINE SYSTEM STRAIGHT ROD HOLDER 6.35mm
• 10705034001319: ISOLA SPINE SYSTEM ROD HOLDER 6.35mm
• 10705034001302: ISOLA SPINE SYSTEM ROD HOLDER 4.75mm
• 10705034184838: ISOLA SPINE SYSTEM HOOK CASE
• 10705034184821: ISOLA SPINE SYSTEM LOW BACK AUXILLARY TRAY
• 10705034004891: ISOLA SPINE SYSTEM IMPLANT/INSTRUMENT CASE
• 10705034001203: ISOLA SPINE SYSTEM OPEN CAP MANIPULATOR 4.75mm
• 10705034001180: ISOLA SPINE SYSTEM HOOK COMPRESSOR
• 10705034001173: ISOLA SPINE SYSTEM COMPRESSOR
• 10705034296128: ISOLA SPINE SYSTEM AWL 90 DEGREES
• 10705034001555: ISOLA SPINE SYSTEM SPINAL AWL
• 10705034241524: ISOLA SPINE SYSTEM SET SCREW 3.17mm
• 10705034184845: ISOLA SPINE SYSTEM TAP 10mm 40-120mm Plus or Minus 1.00 Percent
• 10705034001616: ISOLA SPINE SYSTEM BONE SCREW TAP 8.5mm 40-70mm Plus or Minus 1.00 Percent
• 10705034001609: ISOLA SPINE SYSTEM BONE SCREW TAP 7.75mm 40-70mm Plus or Minus 1.00 Percent
• 10705034001593: ISOLA SPINE SYSTEM BONE SCREW TAP 7mm 40-70mm Plus or Minus 1.00 Percent
• 10705034001586: ISOLA SPINE SYSTEM BONE SCREW TAP 6.25mm 40-70mm Plus or Minus 1.00 Percent