K-FIX®

GUDID 00381780357493

The pack contains five radel K-FIX® ergonomically profiled pin protectors that has three main functions in foot surgery for protruding wires. It protects patients and/or hospital staff from wire sharp ends. It prevents any inward pin migration as well as reducing bandage size. It allows easy removal of the wire by the surgeon. Its fixation requires no instrument. The protector ball is introduced until firm locking on the wire extremity previously bent.

NEWDEAL

Surgical instrument guard, single-use, sterile Surgical instrument guard, single-use, sterile Surgical instrument guard, single-use, sterile Surgical instrument guard, single-use, sterile Surgical instrument guard, single-use, sterile Surgical instrument guard, single-use, sterile Surgical instrument guard, single-use, sterile Surgical instrument guard, single-use, sterile Surgical instrument guard, single-use, sterile Surgical instrument guard, single-use, sterile Surgical instrument guard, single-use, sterile Surgical instrument guard, single-use, sterile Surgical instrument guard, single-use, sterile Surgical instrument guard, single-use, sterile Surgical instrument guard, single-use, sterile Surgical instrument guard, single-use, sterile Surgical instrument guard, single-use, sterile Surgical instrument guard, single-use, sterile Surgical instrument guard, single-use, sterile Surgical instrument guard, single-use, sterile Surgical instrument guard, single-use, sterile Surgical instrument guard, single-use, sterile Surgical instrument guard, single-use, sterile Surgical instrument guard, single-use, sterile Surgical instrument guard, single-use, sterile Surgical instrument guard, single-use, sterile Surgical instrument guard, single-use, sterile Surgical instrument guard, single-use, sterile

• Primary Device ID: 00381780357493
• NIH Device Record Key: a8da6ddf-7fac-486f-b2b6-b6cfe006bc9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-FIX®
• Version Model Number: 119050ND
• Company DUNS: 536935331
• Company Name: NEWDEAL
• Device Count: 5
• 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: 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
• 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
• 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

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
• 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	00381780357493 [Unit of Use]
GS1	10381780045885 [Previous]
GS1	10381780357490 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022597

FDA Product Code

• HTY: PIN, FIXATION, SMOOTH

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-01
• Device Publish Date: 2020-11-23

Devices Manufactured by NEWDEAL

• M248119580ND1 - I.CO.S®: 2024-04-03 The trephine, with a 6.0mm diameter tri shank attachment, is used to core the cortical bone around the 4.0mm compression screw h
• M248119590ND1 - I.CO.S®: 2024-04-03 The trephine, with a 6.0mm diameter tri shank attachment, is used to core the cortical bone around the 6.5mm compression screw h
• M248139107ND1 - METIS®: 2024-02-07 The metatarsal osteotome is used to cut the bone after the pre-cutting stage with the cutting guide, for the insertion of the im
• M248529061ND1 - SURFIX®: 2023-09-18 This K-Wire of diameter 2.5 mm and of length 250 mm is used to guide the instrumentation and the screws.
• 10381780043317 - BASAL DORSAL PLATE: 2023-09-18 The Newdeal sterile Basal Dorsal Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints. It is
• 10381780043324 - BASAL DORSAL PLATE: 2023-09-18 The Newdeal sterile Basal Dorsal Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints. It is
• 10381780043331 - BASAL DORSAL PLATE: 2023-09-18 The Newdeal sterile Basal Dorsal Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints. It is
• 10381780043348 - BASAL DORSAL PLATE: 2023-09-18 The Newdeal sterile Basal Dorsal Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints. It is