CURE LP

GUDID B167S1900455000

MEDITECH SPINE, LLC

Intraoperative bone pin/screw, sterile Intraoperative bone pin/screw, sterile Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use

• Primary Device ID: B167S1900455000
• NIH Device Record Key: e8732f4d-9b19-4205-8c2d-97e217c8fdfc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CURE LP
• Version Model Number: S1-900-455-00
• Company DUNS: 182698477
• Company Name: MEDITECH 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: true
• 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
HIBCC	B167S1900455000 [Primary]
HIBCC	B167S2900455001 [Package]; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171538

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-07

On-Brand Devices [CURE LP]

• B167T940141370: T-9-40141-37
• B167T940141360: T-9-40141-36
• B167T940141350: T-9-40141-35
• B167T940141340: T-9-40141-34
• B167T940141330: T-9-40141-33
• B167T940141320: T-9-40141-32
• B167T940141310: T-9-40141-31
• B167T940141300: T-9-40141-30
• B167T940141290: T-9-40141-29
• B167T940051450: T-9-40051-45
• B167T940051440: T-9-40051-44
• B167T940051430: T-9-40051-43
• B167T940051420: T-9-40051-42
• B167T940051410: T-9-40051-41
• B167T940051400: T-9-40051-40
• B167T940051390: T-9-40051-39
• B167T940051380: T-9-40051-38
• B167T940051370: T-9-40051-37
• B167T940051360: T-9-40051-36
• B167T940051350: T-9-40051-35
• B167T940051340: T-9-40051-34
• B167T940051330: T-9-40051-33
• B167T940041450: T-9-40041-45
• B167T940041440: T-9-40041-44
• B167T940041430: T-9-40041-43
• B167T940041420: T-9-40041-42
• B167T940041410: T-9-40041-41
• B167S4942460602: S1-9-42460-60
• B167S4942460552: S1-9-42460-55
• B167S2942460501: S1-9-42460-50
• B167S4942460452: S1-9-42460-45
• B167S4942460402: S1-9-42460-40
• B167S2942460351: S1-9-42460-35
• B167S4942460302: S1-9-42460-30
• B167S2942460251: S1-9-42460-25
• B167S4942460202: S1-9-42460-20
• B167S2942455601: S1-9-42455-60
• B167S4942455552: S1-9-42455-55
• B167S2942455501: S1-9-42455-50
• B167S2942455451: S1-9-42455-45
• B167S2942455401: S1-9-42455-40
• B167S2942455351: S1-9-42455-35
• B167S2942455301: S1-9-42455-30
• B167S4942455252: S1-9-42455-25
• B167S2942455201: S1-9-42455-20
• B167S2942360601: S1-9-42360-60
• B167S4942360552: S1-9-42360-55
• B167S2942360501: S1-9-42360-50
• B167S2942360451: S1-9-42360-45
• B167S2942360401: S1-9-42360-40