InterPlate® RSB0115

GUDID 00817893021575

SCREW COVER

RSB SPINE LLC

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00817893021575
• NIH Device Record Key: 22ecc81a-66a0-4bff-b93d-ca1007a161c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InterPlate®
• Version Model Number: L-Ti
• Catalog Number: RSB0115
• Company DUNS: 038558909
• Company Name: RSB SPINE LLC
• 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: false
• 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 Dimensions

• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817893021575 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071922

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00817893021575]

Moist Heat or Steam Sterilization

[00817893021575]

Moist Heat or Steam Sterilization

[00817893021575]

Moist Heat or Steam Sterilization

[00817893021575]

Moist Heat or Steam Sterilization

[00817893021575]

Moist Heat or Steam Sterilization

[00817893021575]

Moist Heat or Steam Sterilization

[00817893021575]

Moist Heat or Steam Sterilization

[00817893021575]

Moist Heat or Steam Sterilization

[00817893021575]

Moist Heat or Steam Sterilization

[00817893021575]

Moist Heat or Steam Sterilization

[00817893021575]

Moist Heat or Steam Sterilization

[00817893021575]

Moist Heat or Steam Sterilization

[00817893021575]

Moist Heat or Steam Sterilization

[00817893021575]

Moist Heat or Steam Sterilization

[00817893021575]

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: 2016-09-24

On-Brand Devices [InterPlate®]

• 00817893022084: CASE/TRAY - 25mm TRAY
• 00817893022077: BONE SCREW CADDY - 36 SCREWS
• 00817893022060: 30mm PLATE CADDY
• 00817893022053: 25mm PLATE CADDY
• 00817893022046: CASE/TRAY
• 00817893022039: BONE SCREW CADDY - 24 SCREWS
• 00817893022022: COVER CADDY
• 00817893022015: 12 DEGREE PLATE CADDY
• 00817893022008: 8 DEGREE PLATE CADDY
• 00817893021995: FLEX BONE SCREW DRIVER
• 00817893021940: U-JOINT DRIVER - SHORT
• 00817893021933: U-JOINT DRIVER
• 00817893021926: FREE HAND GUIDE
• 00817893021919: BONE SCREW EXTRACTOR
• 00817893021902: COVER SCREW EXTRACTOR
• 00817893021896: GUIDE INSERTER
• 00817893021889: COVER DRIVER SHAFT
• 00817893021872: COVER DRIVER HANDLE
• 00817893021865: BONE SCREW DRIVER
• 00817893021841: INSERTER
• 00817893021605: BONE SCREW - RESCUE
• 00817893021599: BONE SCREW - STANDARD
• 00817893021582: SCREW COVER
• 00817893021575: SCREW COVER
• 00817893021568: SCREW COVER
• 00817893021551: SCREW COVER
• 00817893021544: SCREW COVER
• 00817893021537: PLATE
• 00817893021520: PLATE
• 00817893021513: PLATE
• 00817893021506: PLATE
• 00817893021490: PLATE
• 00817893021483: PLATE
• 00817893021476: PLATE
• 00817893021469: PLATE
• 00817893021452: PLATE
• 00817893021445: PLATE
• 00817893021438: PLATE
• 00817893021421: PLATE
• 00817893021414: PLATE
• 00817893021407: PLATE
• 00817893021391: PLATE
• 00817893021384: PLATE
• 00817893021377: PLATE
• 00817893021360: PLATE
• 00817893021353: PLATE
• 00817893021346: PLATE
• 00817893021339: PLATE
• 00817893021322: PLATE
• 00817893021315: CASE/TRAY