SURFIX 286212ND

GUDID 10381780049548

Stainless steel Newdeal non sterile locking system fixation consists of screws and washers. This system is available in different sizes. The osteosynthesis screws are fixed to the bone through the plate holes, creating a single implant/screw unit. The system is locked by means of washers drilled into the threaded lipped sockets at the top of each hole, thus blocking each screw head.

NEWDEAL

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 10381780049548
• NIH Device Record Key: 705270ff-2de3-4c97-ab87-8bb86ac96792
• Commercial Distribution Discontinuation: 2027-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURFIX
• Version Model Number: 286212ND
• Catalog Number: 286212ND
• Company DUNS: 536935331
• Company Name: NEWDEAL
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780049548 [Primary]
HIBCC	M248286212ND1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093163

FDA Product Code

• LXT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE

Sterilization

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

[10381780049548]

Moist Heat or Steam Sterilization

[10381780049548]

Moist Heat or Steam Sterilization

[10381780049548]

Moist Heat or Steam Sterilization

[10381780049548]

Moist Heat or Steam Sterilization

[10381780049548]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-02-09
• Device Publish Date: 2017-10-09

On-Brand Devices [SURFIX]

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• 10381780049838: Stainless steel Newdeal non sterile locking system fixation consists of screws and washers. This
• M248286324SND1: Stainless steel Newdeal sterile locking system fixation consists of screws and washers. This sys
• 10381780049814: Stainless steel Newdeal non sterile locking system fixation consists of screws and washers. This
• M248286322SND1: Stainless steel Newdeal sterile locking system fixation consists of screws and washers. This sys
• 10381780049791: Stainless steel Newdeal non sterile locking system fixation consists of screws and washers. This
• 10381780049784: Stainless steel Newdeal sterile locking system fixation consists of screws and washers. This sys