DEVICE: FacetFuse® (00190361019763)

Device Identifier (DI) Information

FacetFuse®
01-00024-ST5550
In Commercial Distribution

SPINEFRONTIER, INC.
00190361019763
GS1

1
002003243 *Terms of Use
Facet Screw Assy, SOTW, Fixed 16, 5.5x50
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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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: 5.5 Millimeter
Length: 50 Millimeter
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Device Record Status

e0923ad3-5bc8-4c39-b4b9-a932070f21d8
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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