PediLoc Fragment System 00-1005-4850

GUDID 00841132108918

4.5mm Contour Plate, 10 Hole

ORTHOPEDIATRICS CORP.

Growth-correction orthopaedic fixation plate kit Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 00841132108918
• NIH Device Record Key: b4c86980-af2a-4dc4-acec-561d0bea070e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PediLoc Fragment System
• Version Model Number: 00-1005-4850
• Catalog Number: 00-1005-4850
• 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: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132108918 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140431

FDA Product Code

• HRS: PLATE, 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-09-28

On-Brand Devices [PediLoc Fragment System]

• 00841132113615: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 70mm
• 00841132113608: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 68mm
• 00841132113592: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 66mm
• 00841132113585: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 65mm
• 00841132113578: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 64mm
• 00841132113561: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 62mm
• 00841132113554: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 60mm
• 00841132113547: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 58mm
• 00841132113530: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 56mm
• 00841132113523: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 55mm
• 00841132113516: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 54mm
• 00841132113509: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 52mm
• 00841132113493: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 50mm
• 00841132113486: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 48mm
• 00841132113479: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 46mm
• 00841132113462: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 45mm
• 00841132113455: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 44mm
• 00841132113448: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 42mm
• 00841132113431: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 40mm
• 00841132113424: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 38mm
• 00841132113417: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 36mm
• 00841132113400: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 35mm
• 00841132113394: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 34mm
• 00841132113387: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 32mm
• 00841132113370: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 30mm
• 00841132113363: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 28mm
• 00841132113356: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 26mm
• 00841132113349: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 25mm
• 00841132113332: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 24mm
• 00841132113325: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 22mm
• 00841132113318: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 20mm
• 00841132113301: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 18mm
• 00841132113295: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 16mm
• 00841132113288: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 15mm
• 00841132113271: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 14mm
• 00841132113264: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 12mm
• 00841132113257: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 10mm
• 00841132113240: 4.0mm Cannulated Cancellous Screw, full thread, T15, 70mm
• 00841132113233: 4.0mm Cannulated Cancellous Screw, full thread, T15, 68mm
• 00841132113226: 4.0mm Cannulated Cancellous Screw, full thread, T15, 66mm
• 00841132113219: 4.0mm Cannulated Cancellous Screw, full thread, T15, 65mm
• 00841132113202: 4.0mm Cannulated Cancellous Screw, full thread, T15, 64mm
• 00841132113196: 4.0mm Cannulated Cancellous Screw, full thread, T15, 62mm
• 00841132113189: 4.0mm Cannulated Cancellous Screw, full thread, T15, 60mm
• 00841132113172: 4.0mm Cannulated Cancellous Screw, full thread, T15, 58mm
• 00841132113165: 4.0mm Cannulated Cancellous Screw, full thread, T15, 56mm
• 00841132113158: 4.0mm Cannulated Cancellous Screw, full thread, T15, 55mm
• 00841132113141: 4.0mm Cannulated Cancellous Screw, full thread, T15, 54mm
• 00841132113134: 4.0mm Cannulated Cancellous Screw, full thread, T15, 52mm
• 00841132113127: 4.0mm Cannulated Cancellous Screw, T15 Hexalobe, full thread, 50mm