ENCINA TAPER FEMORAL STEM STANDARD OFFSET 110-00-001

GUDID 00841176100336

ENCINA TAPER STEM STANDARD OFFSET, SZ 1

STINSON ORTHOPEDICS INC.

Coated hip femur prosthesis, modular

• Primary Device ID: 00841176100336
• NIH Device Record Key: 39fe6878-4b1c-4ded-8002-94ff1f34d1a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENCINA TAPER FEMORAL STEM STANDARD OFFSET
• Version Model Number: 110-00-001
• Catalog Number: 110-00-001
• 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	00841176100336 [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 STANDARD OFFSET]

• 00841176101524: ENCINA TAPER STEM STANDARD OFFSET, SZ 12
• 00841176101517: ENCINA TAPER STEM STANDARD OFFSET, SZ 11
• 00841176100428: ENCINA TAPER STEM STANDARD OFFSET, SZ 10
• 00841176100411: ENCINA TAPER STEM STANDARD OFFSET, SZ 9
• 00841176100404: ENCINA TAPER STEM STANDARD OFFSET, SZ 8
• 00841176100398: ENCINA TAPER STEM STANDARD OFFSET, SZ 7
• 00841176100381: ENCINA TAPER STEM STANDARD OFFSET, SZ 6
• 00841176100374: ENCINA TAPER STEM STANDARD OFFSET, SZ 5
• 00841176100367: ENCINA TAPER STEM STANDARD OFFSET, SZ 4
• 00841176100350: ENCINA TAPER STEM STANDARD OFFSET, SZ 3
• 00841176100343: ENCINA TAPER STEM STANDARD OFFSET, SZ 2
• 00841176100336: ENCINA TAPER STEM STANDARD OFFSET, SZ 1
• 00841176100329: ENCINA TAPER STEM STANDARD OFFSET, SZ 0