5MS™

GUDID 00817906021530

LATERAL NECK PLATE, 8H, L

IN2BONES USA, LLC

Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 00817906021530
• NIH Device Record Key: 43392f34-dba7-43c1-9ae8-362e5fff7acc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 5MS™
• Version Model Number: P60 ST033
• Company DUNS: 079700711
• Company Name: IN2BONES USA, 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
GS1	00817906021530 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170518

FDA Product Code

• HRS: Plate, Fixation, Bone

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: 2017-08-18

On-Brand Devices [5MS™]

• 00817906022698: Plate Screw, Ø2.7 X 30 mm, Locking
• 00817906022681: Plate Screw, Ø2.7 X 28 mm, Locking
• 00817906022674: Plate Screw, Ø2.7 X 26 mm, Locking
• 00817906022667: Plate Screw, Ø2.7 X 24 mm, Locking
• 00817906022650: Plate Screw, Ø2.7 X 22 mm, Locking
• 00817906022643: Plate Screw, Ø2.7 X 20 mm, Locking
• 00817906022636: Plate Screw, Ø2.7 X 18 mm, Locking
• 00817906022629: Plate Screw, Ø2.7 X 16 mm, Locking
• 00817906022612: Plate Screw, Ø2.7 X 15 mm, Locking
• 00817906022605: Plate Screw, Ø2.7 X 14 mm, Locking
• 00817906022599: Plate Screw, Ø2.7 X 13 mm, Locking
• 00817906022582: Plate Screw, Ø2.7 X 12 mm, Locking
• 00817906022575: Plate Screw, Ø2.7 X 11 mm, Locking
• 00817906022568: Plate Screw, Ø2.7 X 10 mm, Locking
• 00817906022551: Plate Screw, Ø2.7 X 9 mm, Locking
• 00817906022544: Plate Screw, Ø2.7 X 8 mm, Locking
• 00817906022537: Plate Screw, Ø2.4 X 30 mm, Locking
• 00817906022520: Plate Screw, Ø2.4 X 28 mm, Locking
• 00817906022513: Plate Screw, Ø2.4 X 26 mm, Locking
• 00817906022506: Plate Screw, Ø2.4 X 24 mm, Locking
• 00817906022490: Plate Screw, Ø2.4 X 22 mm, Locking
• 00817906022483: Plate Screw, Ø2.4 X 20 mm, Locking
• 00817906022476: Plate Screw, Ø2.4 X 18 mm, Locking
• 00817906022469: Plate Screw, Ø2.4 X 16 mm, Locking
• 00817906022452: Plate Screw, Ø2.4 X 15 mm, Locking
• 00817906022445: Plate Screw, Ø2.4 X 14 mm, Locking
• 00817906022438: Plate Screw, Ø2.4 X 13 mm, Locking
• 00817906022421: Plate Screw, Ø2.4 X 12 mm, Locking
• 00817906022414: Plate Screw, Ø2.4 X 11 mm, Locking
• 00817906022407: Plate Screw, Ø2.4 X 10 mm, Locking
• 00817906022391: Plate Screw, Ø2.4 X 9 mm, Locking
• 00817906022384: Plate Screw, Ø2.4 X 8 mm, Locking
• 00817906022377: Plate Screw, Ø2.7 X 30 mm, Non-Locking
• 00817906022360: Plate Screw, Ø2.7 X 28 mm, Non-Locking
• 00817906022353: Plate Screw, Ø2.7 X 26 mm, Non-Locking
• 00817906022346: Plate Screw, Ø2.7 X 24 mm, Non-Locking
• 00817906022339: Plate Screw, Ø2.7 X 22 mm, Non-Locking
• 00817906022322: Plate Screw, Ø2.7 X 20 mm, Non-Locking
• 00817906022315: Plate Screw, Ø2.7 X 18 mm, Non-Locking
• 00817906022308: Plate Screw, Ø2.7 X 16 mm, Non-Locking
• 00817906022292: Plate Screw, Ø2.7 X 15 mm, Non-Locking
• 00817906022285: Plate Screw, Ø2.7 X 14 mm, Non-Locking
• 00817906022278: Plate Screw, Ø2.7 X 13 mm, Non-Locking
• 00817906022261: Plate Screw, Ø2.7 X 12 mm, Non-Locking
• 00817906022254: Plate Screw, Ø2.7 X 11 mm, Non-Locking
• 00817906022247: Plate Screw, Ø2.7 X 10 mm, Non-Locking
• 00817906022230: Plate Screw, Ø2.7 X 9 mm, Non-Locking
• 00817906022223: Plate Screw, Ø2.7 X 8 mm, Non-Locking
• 00817906022216: Plate Screw, Ø2.4 X 30 mm, Non-Locking
• 00817906022209: Plate Screw, Ø2.4 X 28 mm, Non-Locking