AccessGUDID - DEVICE: TOPS™ - 38 S (07290014064089)

GUDID

Device Identifier (DI) Information

Brand Name: TOPS™ - 38 S
Version or Model: 86002
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PREMIA SPINE LTD

Primary DI Number: 07290014064089
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 649220779 *Terms of Use

Device Description: The TOPS™ device is a motion preserving spinal implant that is inserted into the lumbar spine via pedicle screws. The device is implanted via a posterior surgical approach to replace the degenerated skeletal elements such as the lamina and the facet joints that are removed during the decompression.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61198	Posterior lumbar spine prosthesis	A sterile implantable device designed to replace anatomical structures removed from the posterior aspect of lumbar vertebrae (i.e., the lamina, facet joint, and bony elements) during spinal decompression surgery to provide stability to, and enable normal range of motion of, the lumbar spine. It consists of a two-plate unit positioned in the posterior midline, which connects horizontal rods that are attached laterally to adjacent vertebrae with pedicle screws; the plates include interlocking trunnions for rotational/angular motion. The device may be a single unit or modular assembled during implantation. Dedicated tools for implantation are included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
QWK	Prosthesis, Posterior Spinal Elements

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 0 and 70 Percent (%) Relative Humidity
Storage Environment Temperature: between 15 and 22 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d6048717-5d8c-4e4f-98fd-63355ee00647
Public Version Date: November 09, 2023
Public Version Number: 1
DI Record Publish Date: November 01, 2023