ApeX

GUDID 00842078108376

Lag Screw (Solid Tapered) 3.0 x 18mm

EXTREMITY MEDICAL, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00842078108376
• NIH Device Record Key: 8d27f77b-a3ce-4655-9739-5886cac89dbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ApeX
• Version Model Number: 121-30018
• 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	00842078108376 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130120

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00842078108376]

Moist Heat or Steam Sterilization

[00842078108376]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-18
• Device Publish Date: 2019-07-10

On-Brand Devices [ApeX]

• 00842078109304: Large PIP Post - 4.6 x 20mm (45 deg)
• 00842078109281: Large PIP Post - 4.6 x 16mm (45 deg)
• 00842078108987: Large PIP Post - 4.6 x 20mm (30 deg)
• 00842078108963: Large PIP Post - 4.6 x 16mm (30 deg)
• 00842078108918: Medium PIP Post - 4.0 x 20mm (45 deg)
• 00842078108895: Medium PIP Post - 4.0 x 16mm (45 deg)
• 00842078108635: Medium PIP Post - 4.0 x 20mm (30 deg)
• 00842078108611: Medium PIP Post - 4.0 x 16mm (30 deg)
• 00842078108437: Lag Screw (Solid Tapered) 3.0 x 30mm
• 00842078108420: Lag Screw (Solid Tapered) 3.0 x 28mm
• 00842078108413: Lag Screw (Solid Tapered) 3.0 x 26mm
• 00842078108406: Lag Screw (Solid Tapered) 3.0 x 24mm
• 00842078108390: Lag Screw (Solid Tapered) 3.0 x 22mm
• 00842078108383: Lag Screw (Solid Tapered) 3.0 x 20mm
• 00842078108376: Lag Screw (Solid Tapered) 3.0 x 18mm
• 00842078108369: Lag Screw (Solid Tapered) 3.0 x 16mm
• 00842078108246: Apex Instrument Tray