Duns Number:536935331
Device Description: The Hallu-Fix set includes Hallu-Fix S Plates, Hallu-Fix C Plates, screws, and instruments The Hallu-Fix set includes Hallu-Fix S Plates, Hallu-Fix C Plates, screws, and instruments. The Hallu Plates are low profile titanium plates dedicated to first metatarsophalangeal arthrodesis. The system is intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metatarsophalangeal joint.
Catalog Number
HALUINSTSET
Brand Name
HALLU-FIX
Version/Model Number
HALUINSTSET
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"
Yes
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
K021626,K022599,K093781
Product Code
HRS
Product Code Name
PLATE, FIXATION, BONE
Public Device Record Key
02e16aba-bece-4414-97a2-7cb2b69c9ac9
Public Version Date
July 16, 2020
Public Version Number
4
DI Record Publish Date
September 22, 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 | 388 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 235 |