MiniHip Stem 580.0008

GUDID 05055196944923

MINIHIP SIZE 8 STANDARD STEM, BI COATED

CORIN LTD

Coated hip femur prosthesis, modular

• Primary Device ID: 05055196944923
• NIH Device Record Key: 030c1958-0fa6-4aaa-b066-929ac3f3521b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiniHip Stem
• Version Model Number: 580.0008
• Catalog Number: 580.0008
• Company DUNS: 295437313
• Company Name: CORIN LTD
• 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: +441285659866
• Email: lucinda.gerber@coringroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055196944923 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083312

FDA Product Code

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

Sterilization

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

[05055196944923]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-17

On-Brand Devices [MiniHip Stem]

• 05055343891964: Size 1 Broach
• 05055343891957: Size 9 Broach
• 05055343891940: Size 8 Broach
• 05055343891933: Size 7 Broach
• 05055343891926: Size 6 Broach
• 05055343891919: Size 5 Broach
• 05055343891902: Size 4 Broach
• 05055343891896: Size 3 Broach
• 05055343891889: Size 2 Broach
• 05055343880012: Starter Awl
• 05055343879740: Ø36mm Sliding Head
• 05055343879696: Finishing Broach Size 9
• 05055343879689: Finishing Broach Size 8
• 05055343879672: Finishing Broach Size 7
• 05055343879665: Finishing Broach Size 6
• 05055343879658: Finishing Broach Size 5
• 05055343879641: Finishing Broach Size 4
• 05055343879634: Finishing Broach Size 3
• 05055343879627: Finishing Broach Size 2
• 05055343879610: Finishing Broach Size 1
• 05055343879450: Starter Awl Guide
• 05055343879443: Neck Resection Template - Neck
• 05055343879436: Neck Resection Template - Body
• 05055343879382: 48mm Calcar cutter (A/O Drive)
• 05055343879375: 35mm Calcar cutter (A/O Drive)
• 05055343879368: 12/14 Taper Neck Trial (Sizes 7-9)
• 05055343879351: 12/14 Taper Neck Trial (Sizes 4-6)
• 05055343879344: 12/14 Taper Neck Trial (Sizes 1-3)
• 05055343876930: Rib Template Size 9
• 05055343876923: Rib Template Size 8
• 05055343876916: Rib Template Size 7
• 05055343876909: Rib Template Size 5
• 05055343876893: Rib Template Size 6
• 05055343876886: Rib Template Size 4
• 05055343876879: Rib Template Size 3
• 05055343876862: Rib Template Size 2
• 05055343876602: MiniHip - Universal screw Handle
• 05055343869451: Trial Neck-For Male Broach
• 05055196949669: Stem Extractor
• 05055196944954: Curved Starter Awl
• 05055196944947: Stem Impactor
• 05055196944930: MINIHIP SIZE 9 STANDARD STEM, BI COATED
• 05055196944923: MINIHIP SIZE 8 STANDARD STEM, BI COATED
• 05055196944916: MINIHIP SIZE 7 STANDARD STEM, BI COATED
• 05055196944909: MINIHIP SIZE 6 STANDARD STEM, BI COATED
• 05055196944893: MINIHIP SIZE 5 STANDARD STEM, BI COATED
• 05055196944886: MINIHIP SIZE 4 STANDARD STEM, BI COATED
• 05055196944879: MINIHIP SIZE 3 STANDARD STEM, BI COATED
• 05055343879399: MiniHip 35mm Calcar Cutter - Hudson Drive