Duns Number:080506581
Device Description: S-ROM Total Hip System FEMORAL STEM Right XXLong 36 STD NECK +8 11/13 TAPER 18x13x315 Late S-ROM Total Hip System FEMORAL STEM Right XXLong 36 STD NECK +8 11/13 TAPER 18x13x315 Lateral
Catalog Number
563158R
Brand Name
S-ROM
Version/Model Number
56-3158R
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
K851422,P070026,P070026,P070026,P070026,P070026,K910664
Product Code
JDI
Product Code Name
Prosthesis, hip, semi-constrained, metal/polymer, cemented
Public Device Record Key
e1279201-3056-4f42-ae31-4b72859e9cb0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 24, 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 | 5254 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4003 |
| 3 | A medical device with high risk that requires premarket approval | 908 |