DEVICE: TM-400 (04983087007932)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
14106 | Intermittent powered traction system |
An assembly of devices designed to apply and relieve pre-set traction forces from a motor through harnesses typically attached to the cervical or lumbar vertebrae. It usually consists of a mains electricity (AC-powered) motor with a control unit to generate and regulate various intermittent mechanical forces (regular, progressive/regressive, cyclic), and a cord clamped to harnesses to transmit the force. Adjustable spreader bars attached to the control unit may be used to vary the angle at which the cord applies traction. The assembly may be table/wall-mounted for horizontal cervical and lumbar traction, or vertical cervical traction. It is used primarily to widen intervertebral spaces.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ITH | Equipment, Traction, Powered |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K081247 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
06066111-fe0b-46a4-9e8e-1fde8e106c25
November 03, 2023
5
September 24, 2016
November 03, 2023
5
September 24, 2016
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:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined