Orthex 390-70

GUDID 00841132184608

Quick Lock Strut, Small

ORTHOPEDIATRICS CORP.

External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use

• Primary Device ID: 00841132184608
• NIH Device Record Key: 6ebd8b1c-938b-4436-90f5-e1de252cc10c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthex
• Version Model Number: 390-70
• Catalog Number: 390-70
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• 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

Customer Support Contacts

• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132184608 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151881

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[00841132184608]

Moist Heat or Steam Sterilization

[00841132184608]

Moist Heat or Steam Sterilization

[00841132184608]

Moist Heat or Steam Sterilization

[00841132184608]

Moist Heat or Steam Sterilization

[00841132184608]

Moist Heat or Steam Sterilization

[00841132184608]

Moist Heat or Steam Sterilization

[00841132184608]

Moist Heat or Steam Sterilization

[00841132184608]

Moist Heat or Steam Sterilization

[00841132184608]

Moist Heat or Steam Sterilization

[00841132184608]

Moist Heat or Steam Sterilization

[00841132184608]

Moist Heat or Steam Sterilization

[00841132184608]

Moist Heat or Steam Sterilization

[00841132184608]

Moist Heat or Steam Sterilization

[00841132184608]

Moist Heat or Steam Sterilization

[00841132184608]

Moist Heat or Steam Sterilization

[00841132184608]

Moist Heat or Steam Sterilization

[00841132184608]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-26
• Device Publish Date: 2020-03-18

On-Brand Devices [Orthex]

• 00841132180594: X-Ray Ball Attachment, Large Bone
• 00841132180501: Z-Plate, 50mm Ti
• 00841132180495: Orthex Z-Plate, Long, Large Bone, 50mm, Titanium
• 00841132180488: Z-Plate, 50mm
• 00841132180471: Washer, 4mm Square
• 00841132180464: Washer, 4mm Rectangular
• 00841132180457: Washer, 2mm Square
• 00841132180440: Washer, 2mm Rectangular
• 00841132180433: Washer, 1mm Square
• 00841132180426: Washer, 1mm Rectangular
• 00841132180419: Orthex M6 Set Screw, Flat
• 00841132180402: Plate, 4 hole, Orthex
• 00841132180396: Plate, 3 hole, Orthex
• 00841132180389: Plate, 2 hole, Orthex
• 00841132180372: Plate, 1 hole, Orthex
• 00841132180365: FootPlate 230mm Short
• 00841132180358: FootPlate 230mm
• 00841132180341: FootPlate 205mm Short
• 00841132180334: FootPlate 205mm
• 00841132180327: FootPlate 180mm Short
• 00841132180310: FootPlate, Large Bone, 180mm
• 00841132180303: FootPlate 155mm Short
• 00841132180297: FootPlate, Large Bone, 155mm
• 00841132180280: FootPlate 130mm Short
• 00841132180273: FootPlate, Large Bone, 130mm
• 00841132180266: FootPlate 105mm Short
• 00841132180259: FootPlate, Large Bone, 105mm
• 00841132180242: Ring, Full 280mm
• 00841132180235: Ring, Full 255mm
• 00841132180228: Ring, Full 230mm
• 00841132180211: Ring, Full 205mm
• 00841132180204: Ring, Full, Large Bone, 180mm
• 00841132180198: Ring, Full, Large Bone, 155mm
• 00841132180181: Ring, Full, Large Bone, 130mm
• 00841132180174: Ring, Full, Large Bone, 105mm
• 00841132180167: Ring, 5/8 280mm
• 00841132180150: Ring, 5/8 255mm
• 00841132180143: Ring, 5/8 230mm
• 00841132180136: Ring, 5/8 205mm
• 00841132180129: Ring, 5/8, Large Bone, 180mm
• 00841132180112: Ring, 5/8, Large Bone, 155mm
• 00841132180105: Ring, 5/8, Large Bone, 130mm
• 00841132180099: Ring, 5/8, Large Bone, 105mm
• 00841132180082: Ring, Half 280mm
• 00841132180075: Ring, Half 255m
• 00841132180068: Ring, Half 230mm
• 00841132180051: Ring, Half 205mm
• 00841132180044: Ring, Half 180mm
• 00841132180037: Ring, Half 155mm
• 00841132180020: Ring, Half 130mm