Duns Number:828660345
Device Description: osteo-WEDGE Screw Retainer Sleeve, a reusable instrument, for use with the osteo-WEDGE Op osteo-WEDGE Screw Retainer Sleeve, a reusable instrument, for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Catalog Number
GM-150-04
Brand Name
osteo-WEDGE Screw Retainer Sleeve
Version/Model Number
GM-150-04
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K111326
Product Code
HRS
Product Code Name
Plate, Fixation, Bone
Public Device Record Key
db37c7e7-6e0c-4822-a285-e9d6bb3c502a
Public Version Date
October 26, 2021
Public Version Number
4
DI Record Publish Date
April 04, 2017
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 89 |