SURFIX®

GUDID M248286338ND1

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 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 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 Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: M248286338ND1
• NIH Device Record Key: bc173890-edaa-404b-a7c9-f2b4aeab391a
• Commercial Distribution Discontinuation: 2023-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SURFIX®
• Version Model Number: 286338ND
• 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: false
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780057574 [Primary]
HIBCC	M248286338ND1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070447

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[M248286338ND1]

Moist Heat or Steam Sterilization

[M248286338ND1]

Moist Heat or Steam Sterilization

[M248286338ND1]

Moist Heat or Steam Sterilization

[M248286338ND1]

Moist Heat or Steam Sterilization

[M248286338ND1]

Moist Heat or Steam Sterilization

[M248286338ND1]

Moist Heat or Steam Sterilization

[M248286338ND1]

Moist Heat or Steam Sterilization

[M248286338ND1]

Moist Heat or Steam Sterilization

[M248286338ND1]

Moist Heat or Steam Sterilization

[M248286338ND1]

Moist Heat or Steam Sterilization

[M248286338ND1]

Moist Heat or Steam Sterilization

[M248286338ND1]

Moist Heat or Steam Sterilization

[M248286338ND1]

Moist Heat or Steam Sterilization

[M248286338ND1]

Moist Heat or Steam Sterilization

[M248286338ND1]

Moist Heat or Steam Sterilization

[M248286338ND1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-05-02
• Device Publish Date: 2016-12-13

On-Brand Devices [SURFIX®]

• M248MA007ND1: The drilling guide is placed in the plate on the bone and is used to guide the drilling of the b
• M248MA006ND1: The drilling guide is placed in the plate on the bone and is used to guide the drilling of the b
• M248219665ND1: The drilling guide is used to guide the drills while preparing the holes for the 6.5 mm fixation
• M248219645ND1: The drilling guide is used to guide the drills while preparing the holes for the 4.5 mm fixation
• M248219635ND1: The drilling guide is used to guide the drills while preparing the holes for the 3.5 mm fixation
• M248219035ND1: The SURFIX® ALPHA drilling guide for variable angle screws is used to guide the drills while pr
• M248219027ND1: The SURFIX® ALPHA drilling guide is used to guide the drills while preparing the holes for the
• M248SET101ND1: This lid is used to ensure closing of both trays numbers SET000ND and SET100ND.
• M248SET100ND1: This tray is used for transport and sterilization of the instruments that are specific to the os
• M248SET000ND1: This tray is used for transport and sterilization of the instruments that are not specific to th
• M248286340SND1: Stainless steel Newdeal sterile locking system fixation consists of screws and washers. This sys
• M248286340ND1: Stainless steel Newdeal non sterile locking system fixation consists of screws and washers. This
• M248286338SND1: Stainless steel Newdeal sterile locking system fixation consists of screws and washers. This sys
• M248286338ND1: Stainless steel Newdeal non sterile locking system fixation consists of screws and washers. This
• M248286336SND1: Stainless steel Newdeal sterile locking system fixation consists of screws and washers. This sys
• M248286336ND1: Stainless steel Newdeal non sterile locking system fixation consists of screws and washers. This
• M248529061ND1: This K-Wire of diameter 2.5 mm and of length 250 mm is used to guide the instrumentation and the