OrthoPediatrics Titanium PediPlates System 00-1015-8316

GUDID 00841132144909

4.5mm Solid Screw, Standard Profile, Cancellous Thread, 16mm

ORTHOPEDIATRICS CORP.

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00841132144909
• NIH Device Record Key: ce381a6c-b47e-4b6a-ac4c-4961d2673f91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoPediatrics Titanium PediPlates System
• Version Model Number: 00-1015-8316
• Catalog Number: 00-1015-8316
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: true
• 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: Rzorn@OrthoPediatrics.com
• Phone: +1(574)268-6379
• Email: Rzorn@OrthoPediatrics.com
• Phone: +1(574)268-6379
• Email: Rzorn@OrthoPediatrics.com
• Phone: +1(574)268-6379
• Email: Rzorn@OrthoPediatrics.com
• Phone: +1(574)268-6379
• Email: Rzorn@OrthoPediatrics.com
• Phone: +1(574)268-6379
• Email: Rzorn@OrthoPediatrics.com
• Phone: +1(574)268-6379
• Email: Rzorn@OrthoPediatrics.com
• Phone: +1(574)268-6379
• Email: Rzorn@OrthoPediatrics.com
• Phone: +1(574)268-6379
• Email: Rzorn@OrthoPediatrics.com
• Phone: +1(574)268-6379
• Email: Rzorn@OrthoPediatrics.com
• Phone: +1(574)268-6379
• Email: Rzorn@OrthoPediatrics.com
• Phone: +1(574)268-6379
• Email: Rzorn@OrthoPediatrics.com
• Phone: +1(574)268-6379
• Email: Rzorn@OrthoPediatrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132144909 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171173

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-15

On-Brand Devices [OrthoPediatrics Titanium PediPlates System]

• 00841132145029: O-Plate 24mm - Center Hole
• 00841132145012: O-Plate 20mm - Center Hole
• 00841132145005: O-Plate 16mm - Center Hole
• 00841132144992: O-Plate 12mm - Center Hole
• 00841132144985: I-Plate 32mm - Center Hole
• 00841132144978: I-Plate 22mm - Center Hole
• 00841132144961: I-Plate 16mm - Center Hole
• 00841132144954: 4.5mm Solid Screw, Standard Profile, Cancellous Thread, 36mm
• 00841132144947: 4.5mm Solid Screw, Standard Profile, Cancellous Thread, 32mm
• 00841132144930: 4.5mm Solid Screw, Standard Profile, Cancellous Thread, 28mm
• 00841132144923: 4.5mm Solid Screw, Standard Profile, Cancellous Thread, 24mm
• 00841132144916: 4.5mm Solid Screw, Standard Profile, Cancellous Thread, 20mm
• 00841132144909: 4.5mm Solid Screw, Standard Profile, Cancellous Thread, 16mm
• 00841132144893: 4.5mm Cannulated Screw, Standard Profile, Cancellous Thread, 36mm
• 00841132144886: 4.5mm Cannulated Screw, Standard Profile, Cancellous Thread, 32mm
• 00841132144879: 4.5mm Cannulated Screw, Standard Profile, Cancellous Thread, 28mm
• 00841132144862: 4.5mm Cannulated Screw, Standard Profile, Cancellous Thread, 24mm
• 00841132144855: 4.5mm Cannulated Screw, Standard Profile, Cancellous Thread, 20mm
• 00841132144848: 4.5mm Cannulated Screw, Standard Profile, Cancellous Thread, 16mm
• 00841132144831: 4.5mm Solid Screw, Cancellous Thread, 36mm
• 00841132144824: 4.5mm Solid Screw, Cancellous Thread, 32mm
• 00841132144817: 4.5mm Solid Screw, Cancellous Thread, 28mm
• 00841132144800: 4.5mm Solid Screw, Cancellous Thread, 24mm
• 00841132144794: 4.5mm Solid Screw, Cancellous Thread, 20mm
• 00841132144787: 4.5mm Solid Screw, Cancellous Thread, 16mm
• 00841132144770: 4.5mm Cannulated Screw, Cancellous Thread, 36mm
• 00841132144763: 4.5mm Cannulated Screw, Cancellous Thread, 32mm
• 00841132144756: 4.5mm Cannulated Screw, Cancellous Thread, 28mm
• 00841132144749: 4.5mm Cannulated Screw, Cancellous Thread, 24mm
• 00841132144732: 4.5mm Cannulated Screw, Cancellous Thread, 20mm
• 00841132144725: 4.5mm Cannulated Screw, Cancellous Thread, 16mm