ENCINA TAPER A FEMORAL STEM HIGH OFFSET 110-30-011

GUDID 00841176103504

ENCINA TAPER A FEMORAL STEM HIGH OFFSET, SZ 11

STINSON ORTHOPEDICS INC.

Coated hip femur prosthesis, modular

• Primary Device ID: 00841176103504
• NIH Device Record Key: 133578cf-6f5d-4022-9108-4a81456b410e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENCINA TAPER A FEMORAL STEM HIGH OFFSET
• Version Model Number: 110-30-011
• Catalog Number: 110-30-011
• 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	00841176103504 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133370

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: 2017-05-22

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

• 00841176103511: ENCINA TAPER A FEMORAL STEM HIGH OFFSET, SZ 12
• 00841176103504: ENCINA TAPER A FEMORAL STEM HIGH OFFSET, SZ 11
• 00841176103498: ENCINA TAPER A FEMORAL STEM HIGH OFFSET, SZ 10
• 00841176103481: ENCINA TAPER A FEMORAL STEM HIGH OFFSET, SZ 9
• 00841176103474: ENCINA TAPER A FEMORAL STEM HIGH OFFSET, SZ 8
• 00841176103467: ENCINA TAPER A FEMORAL STEM HIGH OFFSET, SZ 7
• 00841176103450: ENCINA TAPER A FEMORAL STEM HIGH OFFSET, SZ 6
• 00841176103443: ENCINA TAPER A FEMORAL STEM HIGH OFFSET, SZ 5
• 00841176103436: ENCINA TAPER A FEMORAL STEM HIGH OFFSET, SZ 4
• 00841176103429: ENCINA TAPER A FEMORAL STEM HIGH OFFSET, SZ 3
• 00841176103412: ENCINA TAPER A FEMORAL STEM HIGH OFFSET, SZ 2
• 00841176103405: ENCINA TAPER A FEMORAL STEM HIGH OFFSET, SZ 1
• 00841176103399: ENCINA TAPER A FEMORAL STEM HIGH OFFSET, SZ 0