Duns Number:348489386
Device Description: A spike has been included in the kit, this is to be inserted through the body of the tube A spike has been included in the kit, this is to be inserted through the body of the tube saw and is used to centralize the saw when starting the cut.
Catalog Number
OST-CBG-17
Brand Name
Osteotec CBG Spike L
Version/Model Number
OST-CBG-17
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
-
Product Code
LXH
Product Code Name
Orthopedic Manual Surgical Instrument
Public Device Record Key
5fb70cf2-2a8c-4e5f-8a65-95b014945aff
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
February 04, 2022
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 | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |