Encompass Hip Stem

GUDID 00822409012961

12mm Cement Restrictor

Ortho Development Corporation

Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile

• Primary Device ID: 00822409012961
• NIH Device Record Key: 48ea0104-ba12-4a5c-b9b3-de2ff437ea08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Encompass Hip Stem
• Version Model Number: 114-2012
• Company DUNS: 876542390
• Company Name: Ortho Development Corporation
• 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: 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(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com

Device Dimensions

• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409012961 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962448

FDA Product Code

• KWY: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-31

On-Brand Devices [Encompass Hip Stem]

• 00822409012992: 18mm Cement Restrictor
• 00822409012985: 16mm Cement Restrictor
• 00822409012978: 14mm Cement Restrictor
• 00822409012961: 12mm Cement Restrictor
• 00822409012954: 10mm Cement Restrictor
• 00822409012947: 9mm Cement Restrictor
• 00822409012886: 18mm Distal Centralizer
• 00822409012879: 17mm Distal Centralizer
• 00822409012862: 16mm Distal Centralizer
• 00822409012855: 15mm Distal Centralizer
• 00822409012848: 14mm Distal Centralizer
• 00822409012831: 13mm Distal Centralizer
• 00822409012824: 12mm Distal Centralizer
• 00822409012817: 11mm Distal Centralizer
• 00822409012800: 10mm Distal Centralizer
• 00822409012794: 9mm Distal Centralizer
• 00822409012015: EXT 12x19mm Stem Cemented
• 00822409012008: EXT 10x17mm Stem Cemented
• 00822409011995: EXT 8x15mm Stem Cemented
• 00822409011988: EXT 6x13mm Stem Cemented
• 00822409011971: STD 12x19mm Stem Cemented
• 00822409011964: STD 10x17mm Stem Cemented
• 00822409011957: STD 8x15mm Stem Cemented
• 00822409011940: STD 6x13mm Stem Cemented
• 00822409011933: 18mm Distal Centralizer
• 00822409011926: 17mm Distal Centralizer
• 00822409011919: 16mm Distal Centralizer
• 00822409011902: 15mm Distal Centralizer
• 00822409011896: 14mm Distal Centralizer
• 00822409011889: 13mm Distal Centralizer
• 00822409011872: 12mm Distal Centralizer
• 00822409011865: 11mm Distal Centralizer
• 00822409011858: 10mm Distal Centralizer
• 00822409011841: 9mm Distal Centralizer