Duns Number:109903521
Device Description: SPEEDSCREW PLUS 6.5 MM PEEK KNOTLESS IMPLANT SET WITH SPEEDSCREW PLUS 6.5 MM PEEK KNOTLESS IMPLANT SET WITH PERFECTPASSER MAGNUMWIRE SUTURE CARTRIDGE, WHITE
Catalog Number
OM-9186
Brand Name
SPEEDSCREW
Version/Model Number
OM-9186
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
Yes
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
K101448
Product Code
HWC
Product Code Name
Screw, fixation, bone
Public Device Record Key
16dc2b1f-bf8a-4139-99be-e429af3990ad
Public Version Date
February 08, 2022
Public Version Number
7
DI Record Publish Date
September 21, 2015
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 | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |