SP-CL Hip Stem 177-542/26

GUDID 04026575260393

Hip Prosthesis Stem, Taper 12 / 14

WALDEMAR LINK GmbH & Co. KG

Coated hip femur prosthesis, modular

• Primary Device ID: 04026575260393
• NIH Device Record Key: da0a5281-bcf9-487d-a989-79d35a3dfff2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SP-CL Hip Stem
• Version Model Number: 177-542/26
• Catalog Number: 177-542/26
• Company DUNS: 315675488
• Company Name: WALDEMAR LINK GmbH & Co. KG
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	04026575260393 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161840

FDA Product Code

• MEH: Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-31
• Device Publish Date: 2020-01-23

On-Brand Devices [SP-CL Hip Stem]

• 04026575260423: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260416: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260409: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260393: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260386: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260362: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260348: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260331: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260324: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260317: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260300: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260294: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260287: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260270: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260263: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260256: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260249: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260232: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260225: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260218: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260201: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260195: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260188: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260171: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260164: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260157: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260140: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260133: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260126: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260119: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260102: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260096: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260089: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260072: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260065: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260041: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260027: Hip Prosthesis Stem, Taper 12 / 14
• 04026575260003: Hip Prosthesis Stem, Taper 12 / 14
• 04026575259991: Hip Prosthesis Stem, Taper 12 / 14
• 04026575259984: Hip Prosthesis Stem, Taper 12 / 14
• 04026575259977: Hip Prosthesis Stem, Taper 12 / 14
• 04026575259960: Hip Prosthesis Stem, Taper 12 / 14
• 04026575259953: Hip Prosthesis Stem, Taper 12 / 14
• 04026575259946: Hip Prosthesis Stem, Taper 12 / 14
• 04026575259939: Hip Prosthesis Stem, Taper 12 / 14
• 04026575259922: Hip Prosthesis Stem, Taper 12 / 14
• 04026575259908: Hip Prosthesis Stem, Taper 12 / 14
• 04026575259892: Hip Prosthesis Stem, Taper 12 / 14
• 04026575259885: Hip Prosthesis Stem, Taper 12 / 14
• 04026575259878: Hip Prosthesis Stem, Taper 12 / 14