Identity
- Trade Name
- S-ROM ZTT FDA UDI
- Generic Name
- Sleeve femoral/tibial extension, coated FDA UDI
- Device Name
- S-ROM Modular Hip System ZTT Proximal Sleeve POROUS COATED 20 F SML FITS: 20 x 15 STEM Cone: F Triangle: SML FDA UDI
- Model / Reference
- 55-0535 FDA UDI
- Description
- S-ROM Modular Hip System ZTT Proximal Sleeve POROUS COATED 20 F SML FITS: 20 x 15 STEM Cone: F Triangle: SML FDA UDI
Identifiers
- Catalog Number
- 550535 FDA UDI
- Primary DI / UDI-DI
- 10603295175353 FDA UDI
- FDA Product Code
- MRA FDA UDILPH FDA UDI
- GMDN Term
- Sleeve femoral/tibial extension, coated FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 888.3358 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sleeve femoral/tibial extension, coated
S-Rom Ztt by Depuy Orthopaedics, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Coated Revision Stem — Signal Medical Corp. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Depuy Orthopaedics, Inc.
Sources (1)
- FDA UDI f41de81a-d5b0-4ed1-8b86-05960654becb 35 fields · synced Jun 8, 2026