Axis Plate

GUDID 00842078117262

Medial Standard Plate (17 Hole)

EXTREMITY MEDICAL, LLC

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 00842078117262
• NIH Device Record Key: e07e071a-9ebb-4bef-bf5b-299087ffb8a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axis Plate
• Version Model Number: 148-10020
• Company DUNS: 832720358
• Company Name: EXTREMITY MEDICAL, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842078117262 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192592

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[00842078117262]

Moist Heat or Steam Sterilization

[00842078117262]

Moist Heat or Steam Sterilization

[00842078117262]

Moist Heat or Steam Sterilization

[00842078117262]

Moist Heat or Steam Sterilization

[00842078117262]

Moist Heat or Steam Sterilization

[00842078117262]

Moist Heat or Steam Sterilization

[00842078117262]

Moist Heat or Steam Sterilization

[00842078117262]

Moist Heat or Steam Sterilization

[00842078117262]

Moist Heat or Steam Sterilization

[00842078117262]

Moist Heat or Steam Sterilization

[00842078117262]

Moist Heat or Steam Sterilization

[00842078117262]

Moist Heat or Steam Sterilization

[00842078117262]

Moist Heat or Steam Sterilization

[00842078117262]

Moist Heat or Steam Sterilization

[00842078117262]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-04
• Device Publish Date: 2020-10-27

On-Brand Devices [Axis Plate]

• 00842078119815: Locking Screw - 4.5 mm x 60
• 00842078119808: Locking Screw - 4.5 mm x 55
• 00842078119792: Locking Screw - 4.5 mm x 50
• 00842078119785: Locking Screw - 4.5 mm x 45
• 00842078119778: Locking Screw - 4.5 mm x 40
• 00842078119761: Locking Screw - 4.5 mm x 35
• 00842078119754: Non-Locking Screw - 4.5 mm x 60
• 00842078119747: Non-Locking Screw - 4.5 mm x 55
• 00842078119730: Non-Locking Screw - 4.5 mm x 50
• 00842078119723: Non-Locking Screw - 4.5 mm x 45
• 00842078119716: Non-Locking Screw - 4.5 mm x 40
• 00842078119709: Non-Locking Screw - 4.5 mm x 35
• 00842078119693: Non-Locking Screw - 4.5 mm x 14
• 00842078119686: Non-Locking Screw - 4.5 mm x 12
• 00842078119679: Locking Screw - 3.5 mm x 60
• 00842078119662: Locking Screw - 3.5 mm x 55
• 00842078119655: Locking Screw - 3.5 mm x 50
• 00842078119648: Locking Screw - 3.5 mm x 45
• 00842078119631: Locking Screw - 3.5 mm x 40
• 00842078119624: Locking Screw - 3.5 mm x 35
• 00842078119617: Locking Screw - 3.5 mm x 14
• 00842078119600: Locking Screw - 3.5 mm x 12
• 00842078119594: Non-Locking Screw - 3.5 mm x 60
• 00842078119587: Non-Locking Screw - 3.5 mm x 55
• 00842078119570: Non-Locking Screw - 3.5 mm x 50
• 00842078119563: Non-Locking Screw - 3.5 mm x 45
• 00842078119556: Non-Locking Screw - 3.5 mm x 40
• 00842078119549: Non-Locking Screw - 3.5 mm x 35
• 00842078119532: Non-Locking Screw - 3.5 mm x 14
• 00842078119525: Non-Locking Screw - 3.5 mm x 12
• 00842078119280: Plantar PlateDistal Medical Column, Right
• 00842078119273: Plantar Plate -Distal Medical Column , Left
• 00842078119266: Plantar Plate, Medium, Right
• 00842078119259: Plantar Plate, Medium, Left
• 00842078119242: Plantar Plate, Short, Right
• 00842078119235: Plantar Plate, Short, Left
• 00842078119129: Locking Screw - 4.5 mm x 14
• 00842078118504: Locking Screw - 4.5 mm x 12
• 00842078118450: Utility Plate (9 Hole)
• 00842078118375: Plantar Plate, Long, Right
• 00842078118368: Plantar Plate, Long, Left
• 00842078117903: Screw Washer
• 00842078117859: Locking Screw - 4.5 mm x 30
• 00842078117842: Locking Screw - 4.5 mm x 28
• 00842078117835: Locking Screw - 4.5 mm x 26
• 00842078117828: Locking Screw - 4.5 mm x 24
• 00842078117811: Locking Screw - 4.5 mm x 22
• 00842078117804: Locking Screw - 4.5 mm x 20
• 00842078117798: Locking Screw - 4.5 mm x 18
• 00842078117781: Locking Screw - 4.5 mm x 16