SURFIX CC028ND

GUDID 10381780051107

SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14 mm to 65 mm.

NEWDEAL

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 10381780051107
• NIH Device Record Key: f1cef319-eb20-4093-afe9-98cf60e41c71
• Commercial Distribution Discontinuation: 2027-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURFIX
• Version Model Number: CC028ND
• Catalog Number: CC028ND
• 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: true
• 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 *Must be stored in a dry, cool place away from dust and UV radiation
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780051107 [Primary]
HIBCC	M248CC028ND1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041601

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

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]

• 10381780057543: Stainless steel Newdeal sterile locking system fixation consists of screws and washers. This sys
• M248SP100ND1: SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2
• 10381780051350: SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2
• 10381780051343: SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2
• 10381780051336: SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2
• 10381780051329: SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2
• 10381780051312: SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2
• 10381780051305: SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2
• 10381780051299: SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2
• 10381780051282: SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2
• 10381780051275: SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2
• 10381780051268: SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2
• 10381780051251: SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2
• M248SP040ND1: SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2
• 10381780051237: SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2
• M248SP030ND1: SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2
• 10381780051213: SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2
• M248SP020ND1: SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2
• 10381780051190: SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14
• 10381780051183: SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14
• 10381780051176: SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14
• 10381780051169: SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14
• M248CC045ND1: SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14
• 10381780051145: SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14
• 10381780051138: SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14
• 10381780051121: SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14
• 10381780051114: SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14
• 10381780051107: SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14
• 10381780051091: SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14
• 10381780051084: SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14
• 10381780051077: SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14
• 10381780051060: SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14
• M248CC018ND1: SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14
• 10381780051046: SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14
• 10381780051039: SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14
• M248286334SND1: Stainless steel Newdeal sterile locking system fixation consists of screws and washers. This sys
• 10381780049913: Stainless steel Newdeal non sterile locking system fixation consists of screws and washers. This
• M248286332SND1: Stainless steel Newdeal sterile locking system fixation consists of screws and washers. This sys
• 10381780049890: Stainless steel Newdeal non sterile locking system fixation consists of screws and washers. This
• 10381780049883: Stainless steel Newdeal sterile locking system fixation consists of screws and washers. This sys
• 10381780049876: Stainless steel Newdeal non sterile locking system fixation consists of screws and washers. This
• M248286328SND1: Stainless steel Newdeal sterile locking system fixation consists of screws and washers. This sys
• 10381780049852: Stainless steel Newdeal non sterile locking system fixation consists of screws and washers. This
• M248286326SND1: Stainless steel Newdeal sterile locking system fixation consists of screws and washers. This sys
• 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