Identity
- Trade Name
- InterSpace Tapered Wedge Stem Trial FDA UDI
- Generic Name
- Hip revision prosthesis trial FDA UDI
- Device Name
- InterSpace Tapered Wedge Stem Trial is intended to be used for the selection of the right size of InterSpace Tapered Wedge Stem to be implanted. FDA UDI
- Model / Reference
- SPC90Z3 FDA UDI
- Description
- InterSpace Tapered Wedge Stem Trial is intended to be used for the selection of the right size of InterSpace Tapered Wedge Stem to be implanted. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08031497002866 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Hip revision prosthesis trial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Hip revision prosthesis trial
InterSpace Tapered Wedge Stem Trial by Tecres — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hip revision prosthesis trial.
- Prosthesis Trial — ADLER ORTHO SPA · Class I
- Trial shaft — ADLER ORTHO SPA · Class I
- Synicem Hip Spacer Trial Case (marked) Regular — BIOCOMPOSITES LTD · Class I
- Trial stem — ADLER ORTHO SPA · Class I
- Synicem 56C Hip Trial FDA — BIOCOMPOSITES LTD · Class I
- Prosthesis Trial — ADLER ORTHO SPA · Class I
- Trial collar — ADLER ORTHO SPA · Class I
- Synicem 48M Hip Trial FDA — BIOCOMPOSITES LTD · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tecres
Sources (1)
- FDA UDI d1bbac04-29e5-4e72-be0b-6371dfa9ab55 33 fields · synced Jun 1, 2026