DEVICE: TIGER Spine System (M72561215010)
Device Identifier (DI) Information
TIGER Spine System
61215-01
In Commercial Distribution
CORELINK LLC
61215-01
In Commercial Distribution
CORELINK LLC
5500 SERIES CONNECTOR RIGHT OFFSET, POLY-AXIAL STANDARD
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? |
---|---|---|---|---|
43257 | Bone-screw internal spinal fixation system |
An assembly of implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Disposable devices associated with implantation may be included.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NKB | Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease |
KWP | Appliance, Fixation, Spinal Interlaminal |
MNH | Orthosis, Spondylolisthesis Spinal Fixation |
MNI | Orthosis, Spinal Pedicle Fixation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: STANDARD |
Device Record Status
485fbe30-8b21-4bc9-8a9c-27c88174c0ef
March 29, 2018
2
September 19, 2014
March 29, 2018
2
September 19, 2014
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
314-863-5401
customer.service@corelinksurgical.com
customer.service@corelinksurgical.com