Duns Number:080506581
Device Description: S-ROM Modular Hip System SPA Proximal Sleeve POROUS COATED 12 B FITS: 12 x 06 OR 12 x 07 S
Catalog Number
535332
Brand Name
S-ROM
Version/Model Number
53-5332
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 11, 2017
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
K071059,P070026,P070026,P070026,P070026,P070026,K912713
Product Code
KWZ
Product Code Name
Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
Public Device Record Key
8c85d322-f07c-4271-8d55-ce003b534e34
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 |