Duns Number:079840876
Device Description: Occipital Plate, 35-45mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation syste Occipital Plate, 35-45mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
Catalog Number
50-8022
Brand Name
Sierra™
Version/Model Number
50-8022
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
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
K080526
Product Code
KWP
Product Code Name
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Public Device Record Key
ef14f6a3-5ef4-4c78-8245-de40730d76ed
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2015
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 | 5602 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14020 |
| U | Unclassified | 21 |