DEVICE: LINEUM OCT SPINE SYSTEM (00888480511335)

Device Identifier (DI) Information

LINEUM OCT SPINE SYSTEM
14-525030
In Commercial Distribution
14-525030
BIOMET SPINE LLC
00888480511335
GS1

1
018577570 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
47831 Orthopaedic implantation sleeve, reusable
A hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MNH Orthosis, spondylolisthesis spinal fixation
MNI Orthosis, spinal pedicle fixation
KWP APPLIANCE, FIXATION, SPINAL INTERLAMINAL
MQP Spinal vertebral body replacement device
MAX Intervertebral fusion device with bone graft, lumbar
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: LINEUM TORQUE STABILIZER LINEUM OCT SPINE SYSTEM
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Device Record Status

031ba26a-6d18-42db-911c-f639d30f411e
January 03, 2025
5
September 29, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)447-3625
USBROCustomerService@zimmerbiomet.com
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