DEVICE: Dynesys® Top-Loading System (00889024285392)
Device Identifier (DI) Information
Dynesys® Top-Loading System
01.03956.045
In Commercial Distribution
Zimmer GmbH
01.03956.045
In Commercial Distribution
Zimmer GmbH
DTL Cann. HA Pedicle+Set screw 6.0x45
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? |
---|---|---|---|---|
61324 | Bone-screw internal spinal fixation system, sterile |
An assembly of sterile 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. Sterile disposable devices associated with implantation may be included.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NQP | POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Length: 45 Millimeter |
Outer Diameter: 6 Millimeter |
Device Record Status
dfb3b216-c3c5-4a31-838b-ed6695c1c5a1
March 29, 2018
2
October 16, 2015
March 29, 2018
2
October 16, 2015
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 |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00889024408050
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)348-2759
zimmer.consumerrelations@zimmer.com
zimmer.consumerrelations@zimmer.com