Duns Number:486741981
Device Description: Hook, in combination with the slap hammer, is intended to help the surgeon to pull/liberat Hook, in combination with the slap hammer, is intended to help the surgeon to pull/liberate the components in area where the access, due to soft tissues, is limited. When the instrument is placed at the femoral distal trochlea groove, it is ideal for pulling off the femoral implant. This is a reusable device.
Catalog Number
T14587
Brand Name
Hook
Version/Model Number
T14587
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
f10b10e3-f527-4754-bf6a-008eb38a4711
Public Version Date
August 28, 2020
Public Version Number
1
DI Record Publish Date
August 20, 2020
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 | 299 |