Duns Number:969820245
Device Description: The bone screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint The bone screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. screws are intended for single use only.
Catalog Number
PD-32-602
Brand Name
ALLY™ Bone Screw-L 12mm
Version/Model Number
PD-32-602
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K121713,K121713
Product Code
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
517bde3c-ccd8-4b84-91f3-874719e2497d
Public Version Date
October 21, 2020
Public Version Number
6
DI Record Publish Date
September 27, 2016
Package DI Number
10852776006314
Quantity per Package
1
Contains DI Package
00852776006317
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |