DEVICE: EVOS Lumbar Interbody System (00841193103884)

Device Identifier (DI) Information

EVOS Lumbar Interbody System
4057-009
In Commercial Distribution
4057-009
Cutting Edge Spine, LLC
00841193103884
GS1

1
069472647 *Terms of Use
HA PEEK EVOS Curved, , 9mmx9mmx 30mm , FLAT 6 degree
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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?
60847 Polymeric spinal fusion cage, sterile
A sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Fixation screws and disposable devices associated with implantation may be included with the device.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
MAX Intervertebral fusion device with bone graft, lumbar
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K150321 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store at room temperature
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Clinically Relevant Size

[?]
Size Type Text
Length: 30 Millimeter
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Device Record Status

6b27a91a-6b71-4242-acaa-868f2209696f
July 06, 2018
3
October 30, 2015
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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)

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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(704)243-0892 10
B.Roof@cuttingedgespine.com
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