Duns Number:348489386
Device Description: To minimize soft tissue damage, two different size displacers have been included in the ki To minimize soft tissue damage, two different size displacers have been included in the kit. The two parts are slotted together and then pushed through the soft tissue until the bone is reached. The central part of the displacer can then be removed, and the tube saw can be inserted. This will stop the saw teeth from ‘snagging’ on and damaging the soft tissue and thus help reduce the recovery time.
Catalog Number
OST-CBG-22
Brand Name
Osteotec CBG Soft Tissue Displacer Large
Version/Model Number
OST-CBG-22
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
513de534-7c4b-4fa2-9a91-463de0a527e5
Public Version Date
February 14, 2022
Public Version Number
1
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 |