CarpalFiX

GUDID 00842078109878

X-Post (60 deg) 4.6 X 12mm

EXTREMITY MEDICAL, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00842078109878
• NIH Device Record Key: 3a3f1707-3564-4eb9-a972-82cc2c6ce8ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CarpalFiX
• Version Model Number: 127-46612
• 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	00842078109878 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121349

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00842078109878]

Moist Heat or Steam Sterilization

[00842078109878]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-23
• Device Publish Date: 2019-07-15

On-Brand Devices [CarpalFiX]

• 00842078109991: X-Post (75 deg) 4.6 X 18mm
• 00842078109984: X-Post (75 deg) 4.6 X 16mm
• 00842078109977: X-Post (75 deg) 4.6 X 14mm
• 00842078109960: X-Post (75 deg) 4.6 X 12mm
• 00842078109953: X-Post (75 deg) 4.6 X 10mm
• 00842078109939: X-Post (60 deg) 4.6 X 18mm
• 00842078109915: X-Post (60 deg) 4.6 X 16mm
• 00842078109892: X-Post (60 deg) 4.6 X 14mm
• 00842078109878: X-Post (60 deg) 4.6 X 12mm
• 00842078109854: X-Post (60 deg) 4.6 X 10mm
• 00842078109830: X-Post (45 deg) 4.6 X 18mm
• 00842078109823: X-Post (45 deg) 4.6 X 16mm
• 00842078109816: X-Post (45 deg) 4.6 X 14mm
• 00842078109809: X-Post (45 deg) 4.6 X 12mm
• 00842078109793: X-Post (45 deg) 4.6 X 10mm
• 00842078109724: Short Thread Lag Screw (Cannulated Tapered) 3.0 x 30mm
• 00842078109717: Short Thread Lag Screw (Cannulated Tapered) 3.0 x 28mm
• 00842078109700: Short Thread Lag Screw (Cannulated Tapered) 3.0 x 26mm
• 00842078109694: Short Thread Lag Screw (Cannulated Tapered) 3.0 x 24mm
• 00842078109687: Short Thread Lag Screw (Cannulated Tapered) 3.0 x 22mm
• 00842078109670: Short Thread Lag Screw (Cannulated Tapered) 3.0 x 20mm
• 00842078109663: Short Thread Lag Screw (Cannulated Tapered) 3.0 x 18mm
• 00842078109656: Short Thread Lag Screw (Cannulated Tapered) 3.0 x 16mm
• 00842078109649: Short Thread Lag Screw (Cannulated Tapered) 3.0 x 14mm
• 00842078109571: Lag Screw (Cannulated Tapered) 3.0 x 30mm
• 00842078109564: Lag Screw (Cannulated Tapered) 3.0 x 28mm
• 00842078109557: Lag Screw (Cannulated Tapered) 3.0 x 26mm
• 00842078109540: Lag Screw (Cannulated Tapered) 3.0 x 24mm
• 00842078109533: Lag Screw (Cannulated Tapered) 3.0 x 22mm
• 00842078109526: Lag Screw (Cannulated Tapered) 3.0 x 20mm
• 00842078109519: Lag Screw (Cannulated Tapered) 3.0 x 18mm
• 00842078109502: Lag Screw (Cannulated Tapered) 3.0 x 16mm
• 00842078109496: Lag Screw (Cannulated Tapered) 3.0 x 14mm
• 00842078109946: X-Post (60 deg) 4.6 x 18 mm (S. Wolfe)
• 00842078109922: X-Post (60 deg) 4.6 x 16 mm (S. Wolfe)
• 00842078109908: X-Post (60 deg) 4.6 x 14 mm (S. Wolfe)
• 00842078109885: X-Post (60 deg) 4.6 x 12 mm (S. Wolfe)
• 00842078109861: X-Post (60 deg) 4.6 x 10 mm (S. Wolfe)
• 00842078109366: Instrument Tray