ENCINA TAPER FEMORAL STEM HIGH OFFSET 110-10-009

GUDID 00841176100527

ENCINA TAPER FEMORAL STEM HIGH OFFSET, SZ 9

STINSON ORTHOPEDICS INC.

Coated hip femur prosthesis, modular

• Primary Device ID: 00841176100527
• NIH Device Record Key: 7f929ac0-ea5a-42b1-85db-623184313eea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENCINA TAPER FEMORAL STEM HIGH OFFSET
• Version Model Number: 110-10-009
• Catalog Number: 110-10-009
• Company DUNS: 080460688
• Company Name: STINSON ORTHOPEDICS INC.
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841176100527 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121297

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, 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: 2016-12-26

On-Brand Devices [ENCINA TAPER FEMORAL STEM HIGH OFFSET]

• 00841176101500: ENCINA TAPER FEMORAL STEM HIGH OFFSET, SZ 12
• 00841176101494: ENCINA TAPER FEMORAL STEM HIGH OFFSET, SZ 11
• 00841176100534: ENCINA TAPER FEMORAL STEM HIGH OFFSET, SZ 10
• 00841176100527: ENCINA TAPER FEMORAL STEM HIGH OFFSET, SZ 9
• 00841176100510: ENCINA TAPER FEMORAL STEM HIGH OFFSET, SZ 8
• 00841176100503: ENCINA TAPER FEMORAL STEM HIGH OFFSET, SZ 7
• 00841176100497: ENCINA TAPER FEMORAL STEM HIGH OFFSET, SZ 6
• 00841176100480: ENCINA TAPER FEMORAL STEM HIGH OFFSET, SZ 5
• 00841176100473: ENCINA TAPER FEMORAL STEM HIGH OFFSET, SZ 4
• 00841176100466: ENCINA TAPER FEMORAL STEM HIGH OFFSET, SZ 3
• 00841176100459: ENCINA TAPER FEMORAL STEM HIGH OFFSET, SZ 2
• 00841176100442: ENCINA TAPER FEMORAL STEM HIGH OFFSET, SZ 1
• 00841176100435: ENCINA TAPER FEMORAL STEM HIGH OFFSET, SZ 0