Duns Number:796416191
Device Description: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 4.5mm, 35mm Length
Catalog Number
00-1350-9435
Brand Name
RESPONSE 5.5/6.0 SPINE SYSTEM
Version/Model Number
00-1350-9435
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K181390
Product Code
KWP
Product Code Name
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Public Device Record Key
73ea919f-1c84-4c4d-a3cf-2cb581663015
Public Version Date
March 13, 2020
Public Version Number
1
DI Record Publish Date
March 05, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1662 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7273 |