DEVICE: INFINITY™ Occipitocervical Upper Thoracic System (00643169549562)

Device Identifier (DI) Information

INFINITY™ Occipitocervical Upper Thoracic System
G3601350
In Commercial Distribution

MEDTRONIC SOFAMOR DANEK, INC.
00643169549562
GS1

1
830350380 *Terms of Use
DOMINO G3601350 OFFSET 3.5 TO 3.5MM
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Device Characteristics

MR Conditional
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?
65114 Bone-screw internal spinal fixation system connector
An implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
NKG Orthosis, cervical pedicle screw spinal fixation
KWP APPLIANCE, FIXATION, SPINAL INTERLAMINAL
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K163375 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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: 3.2/3.5mm to 3.2/3.5mm
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Device Record Status

be063963-335e-4ad7-91ca-8a7b6aa54ac6
September 27, 2024
2
June 10, 2018
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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)633-8766
Corporate.UDI@medtronic.com
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