DEVICE: MONARCH (10705034062747)

Device Identifier (DI) Information

MONARCH
177482050
In Commercial Distribution
177482050
Medos International Sàrl
10705034062747
GS1

1
482661753 *Terms of Use
MONARCH SPINE SYSTEM CLOSED HOOK-WIDE 5.5 x 5mm
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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?
65115 Bone-screw internal spinal fixation system hook
An implantable component of a bone-screw internal spinal fixation system that has a curved (hook-shaped) design 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)]. This component is typically made of metal [e.g., titanium (Ti)] and placed/hooked around the lamina or pedicle of a vertebra, without penetration (i.e., not a screw), to provide a stable connection for the system’s rod; the rod is typically stabilized in the U-shaped hook head with a small lid or screw.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
MNH Orthosis, spondylolisthesis spinal fixation
KWP APPLIANCE, FIXATION, SPINAL INTERLAMINAL
MNI ORTHOSIS, SPINAL PEDICLE FIXATION
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K024348 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

7e8da65b-e1ef-49e3-88b6-8030f6d17987
July 23, 2024
4
September 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(800)255-2500
xx@xx.xx
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