AccessGUDID - DEVICE: Stainless Steel (10889981028572)

GUDID

Device Identifier (DI) Information

Brand Name: Stainless Steel
Version or Model: 25-22-5317
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 25-22-5317
Company Name: SEASPINE ORTHOPEDICS CORPORATION

Primary DI Number: 10889981028572
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079840876 *Terms of Use

Device Description: Adjustable Cross Connector, 53mm-70mm. The Stainless Steel Spinal System consists of a variety of types and sizes of rods, hooks, screws. The Stainless Steel Spinal System implant components can be rigidly locked into a variety of configurations that can be fit for the individual case. The Stainless Steel Spinal System uses components manufactured from 316 LVM stainless steel (ASTM F-138). Unless otherwise instructed, never use this product with components from another manufacturer or system.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	No
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?
57806	Vertebral body prosthesis, non-sterile	A non-sterile implantable device designed to replace or repair (fuse) the spinal bony segments, or vertebrae, lost or injured as a consequence of, e.g., trauma, deformity, tumour, or degenerative disease. It is typically intended to be used with supplemental spinal fixation and may be used with a bone graft. It is usually made of metal, polymer, or a combination of these materials. This device must be sterilized prior to use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KWQ	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL
NKB	Orthosis, spinal pedicle fixation, for degenerative disc disease
MNI	ORTHOSIS, SPINAL PEDICLE FIXATION
MNH	Orthosis, spondylolisthesis spinal fixation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100970	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 53mm-70mm Cross Connector

Device Record Status

Public Device Record Key: fe2cd443-2726-4a6c-aee9-abb88705609c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2015