Biolox® Option

GUDID 00889024276925

BIOLOX® OPTION, head, XL, ø 32/+7, taper 12/14

Zimmer GmbH

Ceramic femoral head prosthesis

• Primary Device ID: 00889024276925
• NIH Device Record Key: 24c5c362-26d1-433e-a7de-a420d272a788
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biolox® Option
• Version Model Number: 00-8777-032-04
• Company DUNS: 488133448
• Company Name: Zimmer GmbH
• 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

Customer Support Contacts

• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com

Device Dimensions

• Outer Diameter: 32 Millimeter
• Device Size Text, specify: 0
• Angle: 7 degree
• Outer Diameter: 32 Millimeter
• Device Size Text, specify: 0
• Angle: 7 degree
• Outer Diameter: 32 Millimeter
• Device Size Text, specify: 0
• Angle: 7 degree
• Outer Diameter: 32 Millimeter
• Device Size Text, specify: 0
• Angle: 7 degree
• Outer Diameter: 32 Millimeter
• Device Size Text, specify: 0
• Angle: 7 degree
• Outer Diameter: 32 Millimeter
• Device Size Text, specify: 0
• Angle: 7 degree
• Outer Diameter: 32 Millimeter
• Device Size Text, specify: 0
• Angle: 7 degree
• Outer Diameter: 32 Millimeter
• Device Size Text, specify: 0
• Angle: 7 degree
• Outer Diameter: 32 Millimeter
• Device Size Text, specify: 0
• Angle: 7 degree
• Outer Diameter: 32 Millimeter
• Device Size Text, specify: 0
• Angle: 7 degree
• Outer Diameter: 32 Millimeter
• Device Size Text, specify: 0
• Angle: 7 degree
• Outer Diameter: 32 Millimeter
• Device Size Text, specify: 0
• Angle: 7 degree
• Outer Diameter: 32 Millimeter
• Device Size Text, specify: 0
• Angle: 7 degree
• Outer Diameter: 32 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024276925 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073567

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-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: 2016-08-29

On-Brand Devices [Biolox® Option]

• 00889024430587: BIOLOX® OPTION, HEAD, XL, Ø 40/+7, TAPER 12/14
• 00889024430570: BIOLOX® OPTION, HEAD, L, Ø 40/+3.5, TAPER 12/14
• 00889024430563: BIOLOX® OPTION, HEAD, M, Ø 40/0, TAPER 12/14
• 00889024430556: BIOLOX® OPTION, HEAD, S, Ø 40/-3.0, TAPER 12/14
• 00889024430549: BIOLOX® OPTION, HEAD, XL, Ø 36/+7, TAPER 12/14
• 00889024430532: BIOLOX® OPTION, HEAD, L, Ø 36/+3.5, TAPER 12/14
• 00889024430525: BIOLOX® OPTION, HEAD, M, Ø 36/0, TAPER 12/14
• 00889024430518: BIOLOX® OPTION, HEAD, S, Ø 36/-3.0, TAPER 12/14
• 00889024430501: BIOLOX® OPTION, HEAD, XL, Ø 32/+7, TAPER 12/14
• 00889024430495: BIOLOX® OPTION, HEAD, L, Ø 32/+3.5, TAPER 12/14
• 00889024430488: BIOLOX® OPTION, HEAD, M, Ø 32/0, TAPER 12/14
• 00889024430471: BIOLOX® OPTION, HEAD, S, Ø 32/-3.0, TAPER 12/14
• 00889024430464: BIOLOX® OPTION, HEAD, XL, Ø 28/+7, TAPER 12/14
• 00889024430457: BIOLOX® OPTION, HEAD, L, Ø 28/+3.5, TAPER 12/14
• 00889024430440: BIOLOX® OPTION, HEAD, M, Ø 28/0, TAPER 12/14
• 00889024430433: BIOLOX® OPTION, HEAD, S, Ø 28/-3.0, TAPER 12/14
• 00889024277007: BIOLOX® OPTION, head, XL, ø 40/+7, taper 12/14
• 00889024276994: BIOLOX® OPTION, head, L, ø 40/+3.5, taper 12/14
• 00889024276987: BIOLOX® OPTION, head, M, ø 40/0, taper 12/14
• 00889024276970: BIOLOX® OPTION, head, S, ø 40/-3.0, taper 12/14
• 00889024276963: BIOLOX® OPTION, head, XL, ø 36/+7, taper 12/14
• 00889024276956: BIOLOX® OPTION, head, L, ø 36/+3.5, taper 12/14
• 00889024276949: BIOLOX® OPTION, head, M, ø 36/0, taper 12/14
• 00889024276932: BIOLOX® OPTION, head, S, ø 36/-3.0, taper 12/14
• 00889024276925: BIOLOX® OPTION, head, XL, ø 32/+7, taper 12/14
• 00889024276918: BIOLOX® OPTION, head, L, ø 32/+3.5, taper 12/14
• 00889024276901: BIOLOX® OPTION, head, M, ø 32/0, taper 12/14
• 00889024276895: Biolox® OPTION Hd/Adpt, 12/14, 32 x -3.0
• 00889024276888: BIOLOX® OPTION, head, XL, ø 28/+7, taper 12/14
• 00889024276871: Biolox® OPTION Hd/Adpt, 12/14, 28 x +3.5
• 00889024276864: BIOLOX® OPTION, head, M, ø 28/0, taper 12/14
• 00889024276857: BIOLOX® OPTION, head, S, ø 28/-3.0, taper 12/14