Rod Transition Set

GUDID 00190837014056

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190837014056
• NIH Device Record Key: e117cd8e-bcc2-4df0-bd14-89acd67e1073
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rod Transition Set
• Version Model Number: 136-155-215
• Company DUNS: 183641617
• Company Name: Life Spine, Inc.
• Device Count: 1
• DM Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190837014056 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141222

FDA Product Code

• NKB: Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Sterilization

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

[00190837014056]

Moist Heat or Steam Sterilization

[00190837014056]

Moist Heat or Steam Sterilization

[00190837014056]

Moist Heat or Steam Sterilization

[00190837014056]

Moist Heat or Steam Sterilization

[00190837014056]

Moist Heat or Steam Sterilization

[00190837014056]

Moist Heat or Steam Sterilization

[00190837014056]

Moist Heat or Steam Sterilization

[00190837014056]

Moist Heat or Steam Sterilization

[00190837014056]

Moist Heat or Steam Sterilization

[00190837014056]

Moist Heat or Steam Sterilization

[00190837014056]

Moist Heat or Steam Sterilization

[00190837014056]

Moist Heat or Steam Sterilization

[00190837014056]

Moist Heat or Steam Sterilization

[00190837014056]

Moist Heat or Steam Sterilization

[00190837014056]

Moist Heat or Steam Sterilization

[00190837014056]

Moist Heat or Steam Sterilization

[00190837014056]

Moist Heat or Steam Sterilization

[00190837014056]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-16

On-Brand Devices [Rod Transition Set]

• 00190837014063: 136-155-235
• 00190837014056: 136-155-215
• 00190837014049: 136-135-235
• 00190837014032: 136-135-195
• 00190837014025: 136-135-185
• 00190837014018: 136-655
• 00190837014001: 136-650
• 00190837013998: 136-645
• 00190837013981: 136-640
• 00190837013974: 136-635
• 00190837013967: 136-630
• 00190837013950: 136-625
• 00190837013943: 136-620
• 00190837013936: 136-440
• 00190837013929: 136-430
• 00190837013912: 136-420
• 00190837013905: 136-540
• 00190837013899: 136-530
• 00190837013882: 136-520
• 00190837013875: 136-355
• 00190837013868: 136-335
• 00190837013851: 136-300
• 00190837013844: 136-255
• 00190837013837: 136-235
• 00190837013820: 136-200
• 00190837013813: 136-155-225
• 00190837013806: 136-135-225
• 00190837013790: 136-102
• 00190837013783: 136-100
• 00190837062507: 136-735-185
• 00190837062491: 136-700
• 00190837062484: 136-600
• 00190837062477: 136-500
• 00190837062460: 136-400
• 00190837062453: 136-1300R
• 00190837062446: 136-1300L
• 00190837062439: 136-1125R
• 00190837062422: 136-1125L
• 00190837062415: 136-1035R
• 00190837062408: 136-1035L
• 00190837062392: 136-103
• 00190837062385: U - Connector Caddy
• 00190837062378: 3.5mm-3.5mm Implant Caddy
• 00190837062361: 5.5mm-5.5mm Implant Caddy
• 00190837062354: 3.5mm-5.5mm Implant Caddy
• 00190837062347: Rod to Rod Connector Inserter
• 00190837062330: Transition Set Supplement Tray Base
• 00190837062323: Transition Set Supplement Tray Top
• 00190837062316: Transition Set Supplement Tray Lid
• 00190837062309: Transition Tray Base