Partial Pelvis Replacement 15-8215/57

GUDID 04026575048601

5 hole flanges

WALDEMAR LINK GmbH & Co. KG

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 04026575048601
• NIH Device Record Key: 07abbe4d-709c-46b0-abad-779806aa126c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Partial Pelvis Replacement
• Version Model Number: 15-8215/57
• Catalog Number: 15-8215/57
• 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: true
• 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	04026575048601 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K943986

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-18
• Device Publish Date: 2015-11-01

On-Brand Devices [Partial Pelvis Replacement]

• 04026575234752: Fixation Screw,for obturator foramen hook, incl. screw lock
• 04026575234745: Fixation Screw,for obturator foramen hook, incl. screw lock
• 04026575200900: 5 hole flanges,with caudal flange
• 04026575200894: 4 hole flanges,with caudal flange
• 04026575200887: 3 hole flanges,with caudal flange
• 04026575200870: 5 hole flanges,with caudal flange
• 04026575200863: 4 hole flanges,with caudal flange
• 04026575200856: 3 hole flanges,with caudal flange
• 04026575200849: 5 hole flanges,with caudal flange
• 04026575200832: 4 hole flanges,with caudal flange
• 04026575200825: 3 hole flanges,with caudal flange
• 04026575200818: 5 hole flanges,with caudal flange
• 04026575200801: 4 hole flanges,with caudal flange
• 04026575200795: 3 hole flanges,with caudal flange
• 04026575200788: 5 hole flanges,with caudal flange
• 04026575200771: 4 hole flanges,with caudal flange
• 04026575200764: 3 hole flanges,with caudal flange
• 04026575200757: 5 hole flanges,with caudal flange
• 04026575200740: 4 hole flanges,with caudal flange
• 04026575200733: 3 hole flanges,with caudal flange
• 04026575200726: 5 hole flanges,with caudal flange
• 04026575200719: 4 hole flanges,with caudal flange
• 04026575200702: 3 hole flanges,with caudal flange
• 04026575200696: 5 hole flanges,with caudal flange
• 04026575200689: 4 hole flanges,with caudal flange
• 04026575200672: 3 hole flanges,with caudal flange
• 04026575200665: 5 hole flanges,with caudal flange
• 04026575200658: 4 hole flanges,with caudal flange
• 04026575200641: 3 hole flanges,with caudal flange
• 04026575200634: 5 hole flanges,with caudal flange
• 04026575200627: 4 hole flanges,with caudal flange
• 04026575200610: 3 hole flanges,with caudal flange
• 04026575200603: 5 hole flanges,with caudal flange
• 04026575200597: 4 hole flanges,with caudal flange
• 04026575200580: 3 hole flanges,with caudal flange
• 04026575200573: 5 hole flanges,with caudal flange
• 04026575200566: 4 hole flanges,with caudal flange
• 04026575200559: 3 hole flanges,with caudal flange
• 04026575048670: Fixation Screw,for obturator foramen hook, incl. screw lock
• 04026575048663: Fixation Screw,for obturator foramen hook, incl. screw lock
• 04026575048656: Hook for obturator foramen
• 04026575048649: Hook for obturator foramen
• 04026575048632: Hook for obturator foramen
• 04026575048625: 5 hole flanges
• 04026575048618: 5 hole flanges
• 04026575048601: 5 hole flanges
• 04026575048595: 5 hole flanges
• 04026575048588: 5 hole flanges
• 04026575048571: 5 hole flanges
• 04026575048564: 4 hole flanges