Entrada Hip Stem

GUDID 00822409036097

Size 11 EXT Collarless

Ortho Development Corporation

Coated hip femur prosthesis, modular

• Primary Device ID: 00822409036097
• NIH Device Record Key: 35e98212-cd8f-470c-849f-935d35b0972b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Entrada Hip Stem
• Version Model Number: 510-1011
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00822409036097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171249

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, 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: 2017-08-29

On-Brand Devices [Entrada Hip Stem]

• 00822409036325: Size 21 EXT Collar
• 00822409036318: Size 20 EXT Collar
• 00822409036301: Size 19 EXT Collar
• 00822409036295: Size 18 EXT Collar
• 00822409036288: Size 17 EXT Collar
• 00822409036271: Size 16 EXT Collar
• 00822409036264: Size 15 EXT Collar
• 00822409036257: Size 14 EXT Collar
• 00822409036240: Size 13 EXT Collar
• 00822409036233: Size 12 EXT Collar
• 00822409036226: Size 11 EXT Collar
• 00822409036219: Size 10 EXT Collar
• 00822409036202: Size 9 EXT Collar
• 00822409036196: Size 21 EXT Collarless
• 00822409036189: Size 20 EXT Collarless
• 00822409036172: Size 19 EXT Collarless
• 00822409036165: Size 18 EXT Collarless
• 00822409036158: Size 17 EXT Collarless
• 00822409036141: Size 16 EXT Collarless
• 00822409036134: Size 15 EXT Collarless
• 00822409036127: Size 14 EXT Collarless
• 00822409036110: Size 13 EXT Collarless
• 00822409036103: Size 12 EXT Collarless
• 00822409036097: Size 11 EXT Collarless
• 00822409036080: Size 10 EXT Collarless
• 00822409036073: Size 9 EXT Collarless
• 00822409036066: Size 21 STD Collar
• 00822409036059: Size 20 STD Collar
• 00822409036042: Size 19 STD Collar
• 00822409036035: Size 18 STD Collar
• 00822409036028: Size 17 STD Collar
• 00822409036011: Size 16 STD Collar
• 00822409036004: Size 15 STD Collar
• 00822409035991: Size 14 STD Collar
• 00822409035984: Size 13 STD Collar
• 00822409035977: Size 12 STD Collar
• 00822409035960: Size 11 STD Collar
• 00822409035953: Size 10 STD Collar
• 00822409035946: Size 9 STD Collar
• 00822409035939: Size 8 STD Collar
• 00822409035922: Size 21 STD Collarless
• 00822409035915: Size 20 STD Collarless
• 00822409035908: Size 19 STD Collarless
• 00822409035892: Size 18 STD Collarless
• 00822409035885: Size 17 STD Collarless
• 00822409035878: Size 16 STD Collarless
• 00822409035861: Size 15 STD Collarless
• 00822409035854: Size 14 STD Collarless
• 00822409035847: Size 13 STD Collarless
• 00822409035830: Size 12 STD Collarless