MaxFuse VBR, 10 (D) x 12 (W) x 32 (H) 62-1012-52

GUDID 00846468055189

10 (D) x 12 (W) x 32 (H)

Pioneer Surgical Technology, Inc.

Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis

Primary Device ID	00846468055189
NIH Device Record Key	ff426d1c-187e-4ad1-a38d-7b9ab67d5214
Commercial Distribution Status	In Commercial Distribution
Brand Name	MaxFuse VBR, 10 (D) x 12 (W) x 32 (H)
Version Model Number	62-1012-52
Catalog Number	62-1012-52
Company DUNS	793384496
Company Name	Pioneer Surgical Technology, 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	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	00846468055189 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K131724

FDA Product Code

MQP	SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

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	2020-02-24
Device Publish Date	2015-11-30

On-Brand Devices [MaxFuse VBR, 10 (D) x 12 (W) x 32 (H)]

00846468055196	10 (D) x 12 (W) x 32 (H), 16 (L)
00846468055189	10 (D) x 12 (W) x 32 (H)