DEVICE: FacetFuse® (00190361020806)

Device Identifier (DI) Information

FacetFuse®
IM0062-04
In Commercial Distribution

SPINEFRONTIER, INC.
00190361020806
GS1

1
002003243 *Terms of Use
FacetFuse Screw, Small Washer Assy, 5.0 x 40mm
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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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
37272 Trans-facet-screw internal spinal fixation system, sterile
A sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
MRW SYSTEM, FACET SCREW SPINAL DEVICE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K071420 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
Outer Diameter: 5 Millimeter
Length: 40 Millimeter
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Device Record Status

d6add1e1-b47f-4ba9-8641-21dad2fec11c
July 06, 2018
4
April 15, 2016
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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
No
No
No CLOSE

Customer Contact

[?]
+1(866)914-7717
customerservice@spinefrontier.com
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