PediFragment 01-1005-1019

GUDID 00841132144718

CLAVICLE PLATE LID

ORTHOPEDIATRICS CORP.

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00841132144718
• NIH Device Record Key: 8c919da4-1e65-411b-b80a-954fa3cdd004
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PediFragment
• Version Model Number: 01-1005-1019
• Catalog Number: 01-1005-1019
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132144718 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203573

FDA Product Code

• FSM: TRAY, SURGICAL, INSTRUMENT
• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[00841132144718]

Moist Heat or Steam Sterilization

[00841132144718]

Moist Heat or Steam Sterilization

[00841132144718]

Moist Heat or Steam Sterilization

[00841132144718]

Moist Heat or Steam Sterilization

[00841132144718]

Moist Heat or Steam Sterilization

[00841132144718]

Moist Heat or Steam Sterilization

[00841132144718]

Moist Heat or Steam Sterilization

[00841132144718]

Moist Heat or Steam Sterilization

[00841132144718]

Moist Heat or Steam Sterilization

[00841132144718]

Moist Heat or Steam Sterilization

[00841132144718]

Moist Heat or Steam Sterilization

[00841132144718]

Moist Heat or Steam Sterilization

[00841132144718]

Moist Heat or Steam Sterilization

[00841132144718]

Moist Heat or Steam Sterilization

[00841132144718]

Moist Heat or Steam Sterilization

[00841132144718]

Moist Heat or Steam Sterilization

[00841132144718]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-08-30

On-Brand Devices [PediFragment]

• 00841132135952: PEDIFRAG FRAGMENT SYSTEM 2.7/3.5 - BASE
• 00841132135945: PEDIFRAG FRAGMENT SYSTEM 2.7/3.5 - 3.5 TRAY
• 00841132133699: PEDILOC FRAGMENT SYSTEM 2.7 3.5
• 00841132133682: PEDILOC FRAGMENT SYSTEM 4.5 - SCREW CADDY LID
• 00841132133675: PEDILOC FRAGMENT SYSTEM 4.5 - SCREW CADDY
• 00841132133668: PEDILOC FRAGMENT SYSTEM 4.5 - 4.5 TRAY
• 00841132133651: PEDILOC FRAGMENT SYSTEM 2.7/3.5 - BASE
• 00841132133644: PEDILOC FRAGMENT SYSTEM 2.7/3.5 - 3.5 TRAY
• 00841132133637: PEDILOC FRAGMENT SYSTEM 2.7/3.5 - 2.7 TRAY
• 00841132133620: PEDILOC FRAGMENT SYSTEM 2.7/3.5 - SCREW CADDY LID
• 00841132133613: PEDILOC FRAGMENT SYSTEM 2.7/3.5 - SCREW CADDY
• 00841132133606: PEDILOC FRAGMENT SYSTEM 2.7/3.5
• 00841132133590: PROVISIONAL REDUCTION DEVICE, SLEEVE, SMALL
• 00841132133583: PROVISIONAL REDUCTION DEVICE. SHAFT, SMALL
• 00841132146088: WRIST FUSION CASE LID
• 00841132146071: WRIST FUSION CASE BASE
• 00841132146064: 2.7MM/3.5MM WRIST FUSION PLATE BENDING TEMPLATE, 99MM
• 00841132144718: CLAVICLE PLATE LID
• 00841132144701: CLAVICLE PLATE CASE
• 00841132144695: WRIST FUSION CASE LID
• 00841132144688: WRIST FUSION CASE BASE
• 00841132144671: 2.7MM/3.5MM WRIST FUSION PLATE BENDING TEMPLATE, 99MM
• 00841132144640: 3.5MM CLAVICLE PLATE, 7 HOLE, LEFT
• 00841132144633: 3.5MM CLAVICLE PLATE, 5 HOLE, LEFT
• 00841132144626: 3.5MM CLAVICLE PLATE, 7 HOLE, RIGHT
• 00841132144619: 3.5MM CLAVICLE PLATE, 5 HOLE, RIGHT
• 00841132144602: 3.5MM CLAVICLE PLATE, 10 HOLE, LEFT
• 00841132144596: 3.5MM CLAVICLE PLATE, 8 HOLE, LEFT
• 00841132144589: 3.5MM CLAVICLE PLATE, 6 HOLE, LEFT
• 00841132144572: 3.5MM CLAVICLE PLATE, 4 HOLE, LEFT
• 00841132144565: 3.5MM CLAVICLE PLATE, 10 HOLE, RIGHT
• 00841132144558: 3.5MM CLAVICLE PLATE, 8 HOLE, RIGHT
• 00841132144541: 3.5MM CLAVICLE PLATE, 6 HOLE, RIGHT
• 00841132144534: 3.5MM CLAVICLE PLATE, 4 HOLE, RIGHT
• 00841132144527: 2.7MM CLAVICLE PLATE, 7 HOLE, LEFT
• 00841132144510: 2.7MM CLAVICLE PLATE, 5 HOLE, LEFT
• 00841132144503: 2.7MM CLAVICLE PLATE, 7 HOLE, RIGHT
• 00841132144497: 2.7MM CLAVICLE PLATE, 5 HOLE, RIGHT
• 00841132144480: 2.7MM CLAVICLE PLATE, 10 HOLE, LEFT
• 00841132144473: 2.7MM CLAVICLE PLATE, 8 HOLE, LEFT
• 00841132144466: 2.7MM CLAVICLE PLATE, 6 HOLE, LEFT
• 00841132144459: 2.7MM CLAVICLE PLATE, 4 HOLE, LEFT
• 00841132144442: 2.7MM CLAVICLE PLATE, 10 HOLE, RIGHT
• 00841132144435: 2.7MM CLAVICLE PLATE, 8 HOLE, RIGHT
• 00841132144428: 2.7MM CLAVICLE PLATE, 6 HOLE, RIGHT
• 00841132144411: 2.7MM CLAVICLE PLATE, 4 HOLE, RIGHT