AccessGUDID - DEVICE: RESPONSE 5.5/6.0 Spine System (00841132136515)

GUDID

Device Identifier (DI) Information

Brand Name: RESPONSE 5.5/6.0 Spine System
Version or Model: 00-1300-6054
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 00-1300-6054
Company Name: ORTHOPEDIATRICS CORP.

Primary DI Number: 00841132136515
Issuing Agency: GS1
Commercial Distribution End Date: September 29, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 796416191 *Terms of Use

Device Description: 6.0MM ROD, TI, SINGLE HEX, 500MM LENGTH

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:	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?
37272	Trans-facet-screw internal spinal fixation system, sterile	A sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL
OSH	Pedicle screw spinal system, adolescent idiopathic scoliosis
MNI	ORTHOSIS, SPINAL PEDICLE FIXATION
MNH	Orthosis, spondylolisthesis spinal fixation
NKB	Thoracolumbosacral pedicle screw system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150600	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4c6c6b55-93ca-461a-ac18-163e8a2955a6
Public Version Date: September 30, 2021
Public Version Number: 5
DI Record Publish Date: February 15, 2017