ENCINA HA FEMORAL STEM STANDARD OFFSET COLLARED 100-20-012

GUDID 00841176100268

ENCINA HA FEMORAL STEM STANDARD OFFSET COLLARED, SZ 12

STINSON ORTHOPEDICS INC.

Coated femoral stem prosthesis, modular

• Primary Device ID: 00841176100268
• NIH Device Record Key: bde7e6af-643a-4f17-83be-b98cfe86f207
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENCINA HA FEMORAL STEM STANDARD OFFSET COLLARED
• Version Model Number: 100-20-012
• Catalog Number: 100-20-012
• 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	00841176100268 [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 HA FEMORAL STEM STANDARD OFFSET COLLARED]

• 00841176100312: ENCINA HA FEMORAL STEM STANDARD OFFSET COLLARED, SZ 18
• 00841176100305: ENCINA HA FEMORAL STEM STANDARD OFFSET COLLARED, SZ 16
• 00841176100299: ENCINA HA FEMORAL STEM STANDARD OFFSET COLLARED, SZ 15
• 00841176100282: ENCINA HA FEMORAL STEM STANDARD OFFSET COLLARED, SZ 14
• 00841176100275: ENCINA HA FEMORAL STEM STANDARD OFFSET COLLARED, SZ 13
• 00841176100268: ENCINA HA FEMORAL STEM STANDARD OFFSET COLLARED, SZ 12
• 00841176100251: ENCINA HA FEMORAL STEM STANDARD OFFSET COLLARED, SZ 11
• 00841176100244: ENCINA HA FEMORAL STEM STANDARD OFFSET COLLARED, SZ 10
• 00841176100237: ENCINA HA FEMORAL STEM STANDARD OFFSET COLLARED, SZ 9
• 00841176100220: ENCINA HA FEMORAL STEM STANDARD OFFSET COLLARED, SZ 8