DEVICE: CoRoent (00887517287663)

Device Identifier (DI) Information

CoRoent
6110925
In Commercial Distribution

Nuvasive, Inc.
00887517287663
GS1

1
053950783 *Terms of Use
CoRoent® LC Ti, 10x9x25mm 8°
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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?
60762 Polymeric spinal interbody fusion cage
A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
MAX Intervertebral fusion device with bone graft, lumbar
MQP SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
ODP Intervertebral fusion device with bone graft, cervical
PHM Intervertebral fusion device with bone graft, thoracic
OVD Intervertebral fusion device with integrated fixation, lumbar
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K120918 000
K140319 000
K140659 000
K141665 000
K141896 000
K150994 000
K151472 000
K153419 000
K160916 000
K161230 000
K163707 000
K170962 000
K231735 000
No CLOSE

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
No Device Sizes
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Device Record Status

86e7f514-f349-4acd-861d-7b8274ca8d84
August 01, 2023
4
October 24, 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)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(858)909-1800
RA_UDI@nuvasive.com
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