Duns Number:942377524
Device Description: Straight Bone Pin - Drill Tip is used by being placed into the bone pin holes to hold the Straight Bone Pin - Drill Tip is used by being placed into the bone pin holes to hold the location and mark the medial resection line of the distal tibia by drilling bicortically through each of the three medial distal holes on the Tibial Cut Guide
Catalog Number
10204025
Brand Name
Cadence™
Version/Model Number
10204025
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
-
Product Code
LXH
Product Code Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Public Device Record Key
02db3977-7c91-4df1-84f8-54706e3bd8a2
Public Version Date
July 10, 2020
Public Version Number
3
DI Record Publish Date
August 24, 2016
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 |