Identity
- Trade Name
- STAR PSI Standard Bundle with Anatomical Models FDA UDI
- Generic Name
- Custom-made orthopaedic/craniofacial surgical guide FDA UDI
- Model / Reference
- 601-00-001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810028394971 FDA UDI
- PMA Number
- P050050 FDA UDI
- FDA Product Code
- NTG FDA UDI
- GMDN Term
- Custom-made orthopaedic/craniofacial surgical guide FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Custom-made orthopaedic/craniofacial surgical guide
STAR PSI Standard Bundle with Anatomical Models by Trilliant Surgical LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P050050 also covers:
- 10mm STAR E+ Sliding Core STAR Total Ankle — Trilliant Surgical LLC
- 11mm STAR E+ Sliding Core STAR Total Ankle — Trilliant Surgical LLC
- 12mm STAR E+ Sliding Core STAR Total Ankle — Trilliant Surgical LLC
- 13mm STAR E+ Sliding Core STAR Total Ankle — Trilliant Surgical LLC
- 14mm E+ Slide Core STAR Implant — Trilliant Surgical LLC
- 14mm STAR E+ Sliding Core STAR Total Ankle — Trilliant Surgical LLC
- 6mm STAR E+ Sliding Core STAR Total Ankle — Trilliant Surgical LLC
- 7mm STAR E+ Sliding Core STAR Total Ankle — Trilliant Surgical LLC
- 8mm STAR E+ Sliding Core STAR Total Ankle — Trilliant Surgical LLC
- 9mm STAR E+ Sliding Core STAR Total Ankle — Trilliant Surgical LLC
- STAR PSI Talus Anatomical Model — Trilliant Surgical LLC
- STAR PSI Talus Cut Guide — Trilliant Surgical LLC
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
- Trilliant Surgical LLC
Sources (1)
- FDA UDI db79a29b-2aef-491b-b9c9-67fa38a8fcf2 33 fields · synced Jun 8, 2026