PediLoc Tibia 00-0903-6211

GUDID 00841132135518

3.5MM NARROW MEDIAL DISTAL TIBIAL COMPRESSION PLATE, 11 HOLE PLATE RIGHT

ORTHOPEDIATRICS CORP.

Growth-correction orthopaedic fixation plate kit

• Primary Device ID: 00841132135518
• NIH Device Record Key: 6f7e19f3-ee9c-4b0b-b96a-bb37729c4843
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PediLoc Tibia
• Version Model Number: 00-0903-6211
• Catalog Number: 00-0903-6211
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132135518 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100240

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-15

On-Brand Devices [PediLoc Tibia]

• 00841132137949: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 34MM LONG, 15MM UNTHREADED TIP
• 00841132137932: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 32MM LONG, 15MM UNTHREADED TIP
• 00841132137925: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 30MM LONG, 15MM UNTHREADED TIP
• 00841132137918: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 38MM LONG, 10MM UNTHREADED TIP
• 00841132137901: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 36MM LONG, 10MM UNTHREADED TIP
• 00841132137895: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 34MM LONG, 10MM UNTHREADED TIP
• 00841132137888: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 32MM LONG, 10MM UNTHREADED TIP
• 00841132137871: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 30MM LONG, 10MM UNTHREADED TIP
• 00841132137154: LOCKING PROXIMAL FEMUR FX SYSTEM
• 00841132137147: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 38MM LONG, 15MM UNTHREADED TIP
• 00841132137130: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 36MM LONG, 15MM UNTHREADED TIP
• 00841132135518: 3.5MM NARROW MEDIAL DISTAL TIBIAL COMPRESSION PLATE, 11 HOLE PLATE RIGHT
• 00841132135501: 3.5MM NARROW MEDIAL DISTAL TIBIAL COMPRESSION PLATE, 9 HOLE PLATE RIGHT
• 00841132135495: 3.5MM NARROW MEDIAL DISTAL TIBIAL COMPRESSION PLATE, 7 HOLE PLATE RIGHT
• 00841132135488: 3.5MM NARROW MEDIAL DISTAL TIBIAL COMPRESSION PLATE, 5 HOLE PLATE RIGHT
• 00841132135471: 3.5MM NARROW MEDIAL DISTAL TIBIAL COMPRESSION PLATE, 4 HOLE PLATE RIGHT
• 00841132135464: 3.5MM NARROW MEDIAL DISTAL TIBIAL COMPRESSION PLATE, 1 HOLE PLATE RIGHT
• 00841132135457: 3.5MM NARROW MEDIAL DISTAL TIBIAL COMPRESSION PLATE, 11 HOLE PLATE LEFT
• 00841132135440: 3.5MM NARROW MEDIAL DISTAL TIBIAL COMPRESSION PLATE, 9 HOLE PLATE LEFT
• 00841132135433: 3.5MM NARROW MEDIAL DISTAL TIBIAL COMPRESSION PLATE, 7 HOLE PLATE LEFT
• 00841132135426: 3.5MM NARROW MEDIAL DISTAL TIBIAL COMPRESSION PLATE, 5 HOLE PLATE LEFT
• 00841132135419: 3.5MM NARROW MEDIAL DISTAL TIBIAL COMPRESSION PLATE, 4 HOLE PLATE LEFT
• 00841132135402: 3.5MM NARROW MEDIAL DISTAL TIBIAL COMPRESSION PLATE, 1 HOLE PLATE LEFT
• 00841132132845: PEDILOC TIBIA CASE LID
• 00841132132838: PEDILOC TIBIA SCREW CADDY
• 00841132132821: PEDILOC TIBIA IMPLANT PLATES TRAY
• 00841132132814: PEDILOC TIBIA CASE SHELL
• 00841132132807: PEDILOC TIBIA IMPLANT SET - 6 AND 8 HOLE PLATES
• 00841132132791: PEDILOC TIBIA FIXATION SYSTEM
• 00841132129777: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 70MM LONG, 15MM UNTHREADED TIP
• 00841132129760: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 68MM LONG, 15MM UNTHREADED TIP
• 00841132129753: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 66MM LONG, 15MM UNTHREADED TIP
• 00841132129746: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 64MM LONG, 15MM UNTHREADED TIP
• 00841132129739: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 62MM LONG, 15MM UNTHREADED TIP
• 00841132129722: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 60MM LONG, 15MM UNTHREADED TIP
• 00841132129715: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 58MM LONG, 15MM UNTHREADED TIP
• 00841132129708: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 56MM LONG, 15MM UNTHREADED TIP
• 00841132129692: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 54MM LONG, 15MM UNTHREADED TIP
• 00841132129685: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 52MM LONG, 15MM UNTHREADED TIP
• 00841132129678: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 50MM LONG, 15MM UNTHREADED TIP
• 00841132129661: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 48MM LONG, 15MM UNTHREADED TIP
• 00841132129654: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 46MM LONG, 15MM UNTHREADED TIP
• 00841132129647: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 44MM LONG, 15MM UNTHREADED TIP
• 00841132129630: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 42MM LONG, 15MM UNTHREADED TIP
• 00841132129623: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 40MM LONG, 15MM UNTHREADED TIP
• 00841132129616: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 70MM LONG, 10MM UNTHREADED TIP
• 00841132129609: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 68MM LONG, 10MM UNTHREADED TIP
• 00841132129593: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 66MM LONG, 10MM UNTHREADED TIP
• 00841132129586: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 64MM LONG, 10MM UNTHREADED TIP
• 00841132129579: 3.5MM TRANS-PHYSEAL LOCKING SCREW, 62MM LONG, 10MM UNTHREADED TIP