AFX

GUDID 00817906028324

AFX, Locking Drill Guide, Ø2.5

IN2BONES USA, LLC

Orthopaedic fixation implant alignment tool

• Primary Device ID: 00817906028324
• NIH Device Record Key: ee514056-9b61-442d-bd48-d2d87babb944
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AFX
• Version Model Number: P07 N0011
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00817906028324 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181113

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00817906028324]

Moist Heat or Steam Sterilization

[00817906028324]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-22
• Device Publish Date: 2018-10-22

On-Brand Devices [AFX]

• 00817906028706: POSTERIOR TIBIA PLATE, 5-HOLE, RIGHT, TRIAL
• 00817906028690: POSTERIOR TIBIA PLATE, 5-HOLE, LEFT, TRIAL
• 00817906028683: POSTERIOR TIBIA PLATE, 3-HOLE, RIGHT, TRIAL
• 00817906028676: POSTERIOR TIBIA PLATE, 3-HOLE, LEFT, TRIAL
• 00817906028669: MEDIAL TIBIA PLATE, 6-HOLE, TRIAL
• 00817906028652: MEDIAL TIBIA PLATE, 4-HOLE, TRIAL
• 00817906028645: POSTEROLATERAL FIBULA PLATE, 7-HOLE, RIGHT, TRIAL
• 00817906028638: POSTEROLATERAL FIBULA PLATE, 7-HOLE, LEFT, TRIAL
• 00817906028621: POSTEROLATERAL FIBULA PLATE, 6-HOLE, RIGHT, TRIAL
• 00817906028614: POSTEROLATERAL FIBULA PLATE, 6-HOLE, LEFT, TRIAL
• 00817906028607: POSTEROLATERAL FIBULA PLATE, 5-HOLE, RIGHT, TRIAL
• 00817906028591: POSTEROLATERAL FIBULA PLATE, 5-HOLE, LEFT, TRIAL
• 00817906028584: POSTEROLATERAL FIBULA PLATE, 4-HOLE, RIGHT, TRIAL
• 00817906028577: POSTEROLATERAL FIBULA PLATE, 4-HOLE, LEFT, TRIAL
• 00817906028560: POSTEROLATERAL FIBULA PLATE, 3-HOLE, RIGHT, TRIAL
• 00817906028553: POSTEROLATERAL FIBULA PLATE, 3-HOLE, LEFT, TRIAL
• 00817906028546: ONE-THIRD TUBULAR PLATE, 12-HOLE, TRIAL
• 00817906028539: ONE-THIRD TUBULAR PLATE, 10-HOLE, TRIAL
• 00817906028522: ONE-THIRD TUBULAR PLATE, 8-HOLE, TRIAL
• 00817906028515: ONE-THIRD TUBULAR PLATE, 6-HOLE, TRIAL
• 00817906028508: ONE-THIRD TUBULAR PLATE, 5-HOLE, TRIAL
• 00817906028492: ONE-THIRD TUBULAR PLATE, 4-HOLE, TRIAL
• 00817906028485: ONE-THIRD TUBULAR PLATE, 3-HOLE, TRIAL
• 00817906028478: LATERAL FIBULA PLATE, 13-HOLE, RIGHT, TRIAL
• 00817906028461: LATERAL FIBULA PLATE, 13-HOLE, LEFT, TRIAL
• 00817906028454: LATERAL FIBULA PLATE, 11-HOLE, RIGHT, TRIAL
• 00817906028447: LATERAL FIBULA PLATE, 11-HOLE, LEFT, TRIAL
• 00817906028430: LATERAL FIBULA PLATE, 9-HOLE, RIGHT, TRIAL
• 00817906028423: LATERAL FIBULA PLATE, 9-HOLE, LEFT, TRIAL
• 00817906028416: LATERAL FIBULA PLATE, 7-HOLE, RIGHT, TRIAL
• 00817906028409: LATERAL FIBULA PLATE, 7-HOLE, LEFT, TRIAL
• 00817906028393: LATERAL FIBULA PLATE, 5-HOLE, RIGHT, TRIAL
• 00817906028386: LATERAL FIBULA PLATE, 5-HOLE, LEFT, TRIAL
• 00817906028379: LATERAL FIBULA PLATE, 4-HOLE, RIGHT, TRIAL
• 00817906028362: LATERAL FIBULA PLATE, 4-HOLE, LEFT, TRIAL
• 00817906028355: LATERAL FIBULA PLATE, 3-HOLE, RIGHT, TRIAL
• 00817906028348: LATERAL FIBULA PLATE, 3-HOLE, LEFT, TRIAL
• 00817906028331: AFX, Locking Drill Guide, Ø1.9
• 00817906028324: AFX, Locking Drill Guide, Ø2.5