PediFrag 00-1005-5010

GUDID 00841132138199

2.7MM CLAVICLE PLATE, 10 HOLE, RIGHT

ORTHOPEDIATRICS CORP.

Growth-correction orthopaedic fixation plate kit

• Primary Device ID: 00841132138199
• NIH Device Record Key: 3e701f91-6d58-4f6a-9350-ae95cd7ab29c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PediFrag
• Version Model Number: 00-1005-5010
• Catalog Number: 00-1005-5010
• 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
• 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
• 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	00841132138199 [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: 2017-07-30

On-Brand Devices [PediFrag]

• 00841132138380: 3.5MM CLAVICLE PLATE, 5 HOLE, LEFT
• 00841132138373: 3.5MM CLAVICLE PLATE, 7 HOLE, RIGHT
• 00841132138366: 3.5MM CLAVICLE PLATE, 5 HOLE, RIGHT
• 00841132138359: 3.5MM CLAVICLE PLATE, 10 HOLE, LEFT
• 00841132138342: 3.5MM CLAVICLE PLATE, 8 HOLE, LEFT
• 00841132138335: 3.5MM CLAVICLE PLATE, 6 HOLE, LEFT
• 00841132138328: 3.5MM CLAVICLE PLATE, 4 HOLE, LEFT
• 00841132138311: 3.5MM CLAVICLE PLATE, 10 HOLE, RIGHT
• 00841132138304: 3.5MM CLAVICLE PLATE, 8 HOLE, RIGHT
• 00841132138298: 3.5MM CLAVICLE PLATE, 6 HOLE, RIGHT
• 00841132138281: 3.5MM CLAVICLE PLATE, 4 HOLE, RIGHT
• 00841132138274: 2.7MM CLAVICLE PLATE, 7 HOLE, LEFT
• 00841132138267: 2.7MM CLAVICLE PLATE, 5 HOLE, LEFT
• 00841132138250: 2.7MM CLAVICLE PLATE, 7 HOLE, RIGHT
• 00841132138243: 2.7MM CLAVICLE PLATE, 5 HOLE, RIGHT
• 00841132138236: 2.7MM CLAVICLE PLATE, 10 HOLE, LEFT
• 00841132138229: 2.7MM CLAVICLE PLATE, 8 HOLE, LEFT
• 00841132138212: 2.7MM CLAVICLE PLATE, 6 HOLE, LEFT
• 00841132138205: 2.7MM CLAVICLE PLATE, 4 HOLE, LEFT
• 00841132138199: 2.7MM CLAVICLE PLATE, 10 HOLE, RIGHT
• 00841132138182: 2.7MM CLAVICLE PLATE, 8 HOLE, RIGHT
• 00841132138175: 2.7MM CLAVICLE PLATE, 6 HOLE, RIGHT
• 00841132138168: 2.7MM CLAVICLE PLATE, 4 HOLE, RIGHT
• 00841132137239: PEDIFRAG SMALL AND MINI FRAGMENT SYSTEM (2.7/3.5/4.0) BOM
• 00841132130452: PEDILOC FRAGMENT SYSTEM 2.7/3.5- 2.7 TRAY, SMALL
• 00841132130445: PEDILOC FRAGMENT SYSTEM SCREW CADDY LID
• 00841132130438: PEDILOC FRAGMENT SYSTEM SCREW CADDY
• 00841132130421: PEDILOC FRAGMENT SYSTEM 2.7/3.5- 3.5 TRAY, SMALL
• 00841132130414: PEDILOC FRAGMENT SYSTEM 2.7/3.5- 2.7 TRAY, SMALL
• 00841132130407: PEDIFRAG TRAY, BASE
• 00841132138410: CLAVICLE PLATE LID
• 00841132138403: CLAVICLE PLATE TRAY
• 00841132122716: T10 RETAINING DRIVER, SHORT
• 00841132122709: T10 HEXALOBE DRIVER, SHORT
• 00841132122662: T15 CANNULATED DRIVER, SHORT (DIA 1.25)
• 00841132122655: 2.5 MM X 150 MM GUIDE WIRE, THREADED
• 00841132122648: PLATE FIXATION PIN
• 00841132122631: T15 HEXALOBE DRIVER, RETAINING
• 00841132122624: T10 HEXALOBE DRIVER, RETAINING
• 00841132122617: CANNULATED COUNTERSINK
• 00841132122600: 3.5 MM DRILL BIT
• 00841132122594: 2.7 MM DRILL BIT
• 00841132122587: 2.0 MM CALIBRATED DRILL BIT
• 00841132122570: 2.0 MM DRILL BIT
• 00841132138397: 3.5MM CLAVICLE PLATE, 7 HOLE, LEFT