Omni Stable AF

GUDID 00842078126196

Solid Screw, Non-Locking, 4.0 x 54mm

EXTREMITY MEDICAL, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00842078126196
• NIH Device Record Key: 0f0a8b1d-85d2-41d2-ba01-7395ac3d984b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omni Stable AF
• Version Model Number: 155-40054
• 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	00842078126196 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212297

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00842078126196]

Moist Heat or Steam Sterilization

[00842078126196]

Moist Heat or Steam Sterilization

[00842078126196]

Moist Heat or Steam Sterilization

[00842078126196]

Moist Heat or Steam Sterilization

[00842078126196]

Moist Heat or Steam Sterilization

[00842078126196]

Moist Heat or Steam Sterilization

[00842078126196]

Moist Heat or Steam Sterilization

[00842078126196]

Moist Heat or Steam Sterilization

[00842078126196]

Moist Heat or Steam Sterilization

[00842078126196]

Moist Heat or Steam Sterilization

[00842078126196]

Moist Heat or Steam Sterilization

[00842078126196]

Moist Heat or Steam Sterilization

[00842078126196]

Moist Heat or Steam Sterilization

[00842078126196]

Moist Heat or Steam Sterilization

[00842078126196]

Moist Heat or Steam Sterilization

[00842078126196]

Moist Heat or Steam Sterilization

[00842078126196]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-20
• Device Publish Date: 2023-06-12

On-Brand Devices [Omni Stable AF]

• 00842078130148: Straight Plate, 2 Holes
• 00842078130117: Hook Plate, 7 Holes (5 Proximal)
• 00842078130100: Hook Plate, 5 Holes (3 Proximal)
• 00842078130094: Posterior Fibula Plate, 13 Holes (9 Proximal), Right
• 00842078130087: Posterior Fibula Plate, 13 Holes (9 Proximal), Left
• 00842078130070: Posterior Fibula Plate, 11 Holes (7 Proximal), Right
• 00842078130063: Posterior Fibula Plate, 11 Holes (7 Proximal), Left
• 00842078130056: Posterior Fibula Plate, 9 Holes (5 Proximal), Right
• 00842078130049: Posterior Fibula Plate, 9 Holes (5 Proximal), Left
• 00842078130018: Lateral Fibula Plate, 15 Holes (9 Proximal), Right
• 00842078130001: Lateral Fibula Plate, 15 Holes (9 Proximal), Left
• 00842078129999: Lateral Fibula Plate, 13 Holes (7 Proximal), Right
• 00842078129982: Lateral Fibula Plate, 13 Holes (7 Proximal), Left
• 00842078129975: Lateral Fibula Plate, 11 Holes (5 Proximal), Right
• 00842078129968: Lateral Fibula Plate, 11 Holes (5 Proximal), Left
• 00842078126059: Posterior Fibula Plate, 15 Holes (11 Proximal), Right
• 00842078126042: Lateral Fibula Plate, 19 Holes (13 Proximal), Right
• 00842078126011: Posterior Fibula Plate, 15 Holes (11 Proximal), Left
• 00842078126004: Lateral Fibula Plate, 19 Holes (13 Proximal), Left
• 00842078125984: Straight Plate, 16 Holes
• 00842078125953: Straight Plate, 14 Holes
• 00842078124161: Lateral Fibula Plate, 17 Holes (11 Proximal), Right
• 00842078124154: Lateral Fibula Plate, 17 Holes (11 Proximal), Left
• 00842078122822: Anterior Tibia Plate, 17 Holes (7 Proximal)
• 00842078122815: Anterior Tibia Plate, 15 Holes (5 Proximal)
• 00842078122778: Posterior Tibia Plate, L-Shape, 9 Holes (7 Proximal), Right
• 00842078122761: Posterior Tibia Plate, L-Shape, 9 Holes (7 Proximal), Left
• 00842078122754: Posterior Tibia Plate, L-Shape, 7 Holes (5 Proximal), Right
• 00842078122747: Posterior Tibia Plate, L-Shape, 7 Holes (5 Proximal), Left
• 00842078122730: Posterior Tibia Plate, L-Shape, 5 Holes (3 Proximal), Right
• 00842078122723: Posterior Tibia Plate, L-Shape, 5 Holes (3 Proximal), Left
• 00842078122709: Posterior Tibia Plate, Y-Shape, 9 Holes (7 Proximal)
• 00842078122693: Posterior Tibia Plate, Y-Shape, 7 Holes (5 Proximal)
• 00842078122686: Posterior Tibia Plate, Y-Shape, 5 Holes (3 Proximal)
• 00842078122679: Straight Plate, 12 Holes
• 00842078122662: Straight Plate, 10 Holes
• 00842078122655: Straight Plate, 8 Holes
• 00842078122648: Straight Plate, 6 Holes
• 00842078122631: Straight Plate, 4 Holes
• 00842078128565: Locking Screw - 2.8 x 60mm
• 00842078128558: Non-Locking Screw - 2.8 x 60mm
• 00842078128480: Locking Screw - 2.8 x 58mm
• 00842078128473: Non-Locking Screw - 2.8 x 58mm
• 00842078128404: Locking Screw - 2.8 x 56mm
• 00842078128398: Non-Locking Screw - 2.8 x 56mm
• 00842078128329: Locking Screw - 2.8 x 54mm
• 00842078128312: Non-Locking Screw - 2.8 x 54mm
• 00842078128244: Locking Screw - 2.8 x 52mm
• 00842078128237: Non-Locking Screw - 2.8 x 52mm
• 00842078128169: Locking Screw - 2.8 x 50mm