DEVICE: Accu Spina / Spina System Cervical (00869444000218)

Device Identifier (DI) Information

Accu Spina / Spina System Cervical
21
In Commercial Distribution

NORTH AMERICAN MEDICAL CORPORATION
00869444000218
GS1

1
031023091 *Terms of Use
Physiotherapeutic treament device
CLOSE

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?
45537 Static/intermittent powered traction system, non-mobile
An assembly of devices capable of applying continuous and various intermittent (regular, progressive/regressive, cycled) traction forces from a motor through harnesses typically attached to the cervical or lumbar vertebrae. It usually consists of an AC-powered motor with a control unit used to generate and regulate the mechanical forces, 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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
ITH Equipment, Traction, Powered
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K033231 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between 0 and 50 Degrees Celsius
Handling Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 128 Inch
Width: 58 Inch
Height: 88 Inch
CLOSE

Device Record Status

df6ba08c-8bf6-4e9d-91fc-594ae3d9a749
July 06, 2018
3
September 24, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
770-541-0012
office@namcorporation.com
CLOSE