Orthex Half Pin HP60-150-20B

GUDID 00841132184028

Orthex Ultima Half Pin, Large Bone, 6.0mmx150mmx20mm, HA Coated, Button Tip, Sterile

ORTHOPEDIATRICS CORP.

External orthopaedic fixation system, single-use, sterile

• Primary Device ID: 00841132184028
• NIH Device Record Key: 3da01261-98c0-437d-bc64-98532b360ea7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthex Half Pin
• Version Model Number: HP60-150-20B
• Catalog Number: HP60-150-20B
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: false
• 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: true
• 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: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132184028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052196

FDA Product Code

• JDW: PIN, FIXATION, THREADED

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-10
• Device Publish Date: 2020-03-02

On-Brand Devices [Orthex Half Pin]

• 00841132184530: Orthex Ultima Half Pin, Small Bone, 5.0mmx150mmx60mm, HA Coated, Button Tip, Sterile
• 00841132184523: Orthex Ultima Half Pin, Small Bone, 5.0mmx150mmx55mm, HA Coated, Button Tip, Sterile
• 00841132184516: Orthex Ultima Half Pin, Small Bone, 5.0mmx150mmx50mm, HA Coated, Button Tip, Sterile
• 00841132184509: Orthex Ultima Half Pin, Small Bone, 5.0mmx200mmx60mm, HA Coated, Button Tip, Sterile
• 00841132184493: Orthex Ultima Half Pin, Small Bone, 5.0mmx200mmx55mm, HA Coated, Button Tip, Sterile
• 00841132184486: Orthex Ultima Half Pin, Small Bone, 5.0mmx200mmx50mm, HA Coated, Button Tip, Sterile
• 00841132184479: Orthex Ultima Half Pin, Small Bone, 5.0mmx200mmx45mm, HA Coated, Button Tip, Sterile
• 00841132184462: Orthex Ultima Half Pin, Small Bone, 5.0mmx200mmx40mm, HA Coated, Button Tip, Sterile
• 00841132184455: Orthex Ultima Half Pin, Small Bone, 5.0mmx200mmx35mm, HA Coated, Button Tip, Sterile
• 00841132184448: Orthex Ultima Half Pin, Small Bone, 5.0mmx200mmx30mm, HA Coated, Button Tip, Sterile
• 00841132184431: Orthex Ultima Half Pin, Small Bone, 5.0mmx200mmx25mm, HA Coated, Button Tip, Sterile
• 00841132184424: Orthex Ultima Half Pin, Small Bone, 5.0mmx200mmx20mm, HA Coated, Button Tip, Sterile
• 00841132184417: Orthex Ultima Half Pin, Small Bone, 5.0mmx200mmx15mm, HA Coated, Button Tip, Sterile
• 00841132184400: Orthex Ultima Half Pin, Small Bone, 4.0mmx150mmx60mm, HA Coated, Button Tip, Sterile
• 00841132184394: Orthex Ultima Half Pin, Small Bone, 4.0mmx150mmx55mm, HA Coated, Button Tip, Sterile
• 00841132184387: Orthex Ultima Half Pin, Small Bone, 4.0mmx150mmx50mm, HA Coated, Button Tip, Sterile
• 00841132184370: Orthex Ultima Half Pin, Small Bone, 4.0mmx150mmx45mm, HA Coated, Button Tip, Sterile
• 00841132184363: Orthex Ultima Half Pin, Small Bone, 4.0mmx200mmx60mm, HA Coated, Button Tip, Sterile
• 00841132184356: Orthex Ultima Half Pin, Small Bone, 4.0mmx200mmx55mm, HA Coated, Button Tip, Sterile
• 00841132184349: Orthex Ultima Half Pin, Small Bone, 4.0mmx200mmx50mm, HA Coated, Button Tip, Sterile
• 00841132184332: Orthex Ultima Half Pin, Small Bone, 4.0mmx200mmx45mm, HA Coated, Button Tip, Sterile
• 00841132184325: Orthex Ultima Half Pin, Small Bone, 4.0mmx200mmx40mm, HA Coated, Button Tip, Sterile
• 00841132184318: Orthex Ultima Half Pin, Small Bone, 4.0mmx200mmx35mm, HA Coated, Button Tip, Sterile
• 00841132184301: Orthex Ultima Half Pin, Small Bone, 4.0mmx200mmx30mm, HA Coated, Button Tip, Sterile
• 00841132184295: Orthex Ultima Half Pin, Small Bone, 4.0mmx200mmx25mm, HA Coated, Button Tip, Sterile
• 00841132184288: Orthex Ultima Half Pin, Small Bone, 4.0mmx200mmx20mm, HA Coated, Button Tip, Sterile
• 00841132184271: Orthex Ultima Half Pin, Small Bone, 4.0mmx200mmx15mm, HA Coated, Button Tip, Sterile
• 00841132184264: Orthex Ultima Half Pin, Small Bone, 4.0mmx200mmx10mm, HA Coated, Button Tip, Sterile
• 00841132184257: Orthex Ultima Half Pin, Small Bone, 3.0mmx150mmx60mm, HA Coated, Button Tip, Sterile
• 00841132184240: Orthex Ultima Half Pin, Small Bone, 3.0mmx150mmx55mm, HA Coated, Button Tip, Sterile
• 00841132184233: Orthex Ultima Half Pin, Small Bone, 3.0mmx150mmx50mm, HA Coated, Button Tip, Sterile
• 00841132184226: Orthex Ultima Half Pin, Small Bone, 3.0mmx150mmx45mm, HA Coated, Button Tip, Sterile
• 00841132184219: Orthex Ultima Half Pin, Small Bone, 3.0mmx200mmx60mm, HA Coated, Button Tip, Sterile
• 00841132184202: Orthex Ultima Half Pin, Small Bone, 3.0mmx200mmx55mm, HA Coated, Button Tip, Sterile
• 00841132184196: Orthex Ultima Half Pin, Small Bone, 3.0mmx200mmx50mm, HA Coated, Button Tip, Sterile
• 00841132184189: Orthex Ultima Half Pin, Small Bone, 3.0mmx200mmx45mm, HA Coated, Button Tip, Sterile
• 00841132184172: Orthex Ultima Half Pin, Small Bone, 3.0mmx200mmx40mm, HA Coated, Button Tip, Sterile
• 00841132184165: Orthex Ultima Half Pin, Small Bone, 3.0mmx200mmx35mm, HA Coated, Button Tip, Sterile
• 00841132184158: Orthex Ultima Half Pin, Small Bone, 3.0mmx200mmx30mm, HA Coated, Button Tip, Sterile
• 00841132184141: Orthex Ultima Half Pin, Small Bone, 3.0mmx200mmx25mm, HA Coated, Button Tip, Sterile
• 00841132184134: Orthex Ultima Half Pin, Small Bone, 3.0mmx200mmx20mm, HA Coated, Button Tip, Sterile
• 00841132184127: Orthex Ultima Half Pin, Small Bone, 3.0mmx200mmx15mm, HA Coated, Button Tip, Sterile
• 00841132184110: Orthex Ultima Half Pin, Small Bone, 3.0mmx200mmx10mm, HA Coated, Button Tip, Sterile
• 00841132184103: Orthex Ultima Half Pin, Large Bone, 6.0mmx150mmx60mm, HA Coated, Button Tip, Sterile
• 00841132184097: Orthex Ultima Half Pin, Large Bone, 6.0mmx150mmx55mm, HA Coated, Button Tip, Sterile
• 00841132184080: Orthex Ultima Half Pin, Large Bone, 6.0mmx150mmx50mm, HA Coated, Button Tip, Sterile
• 00841132184073: Orthex Ultima Half Pin, Large Bone, 6.0mmx150mmx45mm, HA Coated, Button Tip, Sterile
• 00841132184066: Orthex Ultima Half Pin, Large Bone, 6.0mmx150mmx40mm, HA Coated, Button Tip, Sterile
• 00841132184059: Orthex Ultima Half Pin, Large Bone, 6.0mmx150mmx35mm, HA Coated, Button Tip, Sterile
• 00841132184042: Orthex Ultima Half Pin, Large Bone, 6.0mmx150mmx30mm, HA Coated, Button Tip, Sterile