CompressX

GUDID 00842078101346

Compression Screw - 6.5 x 35

EXTREMITY MEDICAL, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00842078101346
• NIH Device Record Key: 35573b8c-ef7e-48da-83e0-4231466fb296
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CompressX
• Version Model Number: 101-65035-2
• 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	00842078101346 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081934

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00842078101346]

Moist Heat or Steam Sterilization

[00842078101346]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-05
• Device Publish Date: 2019-06-27

On-Brand Devices [CompressX]

• 00842078101469: 6.5 x 65mm CompressX Compression Screw
• 00842078101568: Compression Screw - 6.5 x 90
• 00842078101544: Compression Screw - 6.5 x 85
• 00842078101520: Compression Screw - 6.5 x 80
• 00842078101506: Compression Screw - 6.5 x 75
• 00842078101483: Compression Screw - 6.5 x 70
• 00842078101445: Compression Screw - 6.5 x 60
• 00842078101421: Compression Screw - 6.5 x 55
• 00842078101407: Compression Screw - 6.5 x 50
• 00842078101384: Compression Screw - 6.5 x 45
• 00842078101360: Compression Screw - 6.5 x 40
• 00842078101346: Compression Screw - 6.5 x 35
• 00842078101322: Compression Screw - 6.5 x 30
• 00842078101186: Compression Screw - 4.5 x 60
• 00842078101148: Compression Screw - 4.5 x 56
• 00842078101100: Compression Screw - 4.5 x 52
• 00842078101063: Compression Screw - 4.5 x 48
• 00842078101025: Compression Screw - 4.5 x 44
• 00842078100981: Compression Screw - 4.5 x 40
• 00842078100967: Compression Screw - 4.5 x 38
• 00842078100943: Compression Screw - 4.5 x 36
• 00842078100929: Compression Screw - 4.5 x 34
• 00842078100905: Compression Screw - 4.5 x 32
• 00842078100868: Compression Screw - 4.5 x 28
• 00842078100844: Compression Screw - 4.5 x 26
• 00842078100882: Compression Screw - 4.5 x 30