Duns Number:942377524
Device Description: The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for b The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for bone fracturesor osteotomies in the ankle and foot
Catalog Number
TBW-1006-SM8
Brand Name
Integra® Titanium Bone Wedge System
Version/Model Number
TBW-1006-SM8
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
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
K131360
Product Code
HRS
Product Code Name
PLATE, FIXATION, BONE
Public Device Record Key
5429aefc-7c15-4474-9141-e5f928d1aeeb
Public Version Date
June 08, 2021
Public Version Number
5
DI Record Publish Date
October 09, 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 | 1909 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1404 |
| 3 | A medical device with high risk that requires premarket approval | 12 |
| U | Unclassified | 15 |