Identity
- Trade Name
- Tiger FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- 5.5mm x 35mm STTCS FDA UDI
- Model / Reference
- 205-55-035 FDA UDI
- Description
- 5.5mm x 35mm STTCS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812926024080 FDA UDI
- 510(k) Number
- K153338 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Orthopaedic bone screw (non-sliding)
Tiger by Trilliant Surgical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw (non-sliding).
- EVOS — Smith & Nephew, Inc. · Class II
- TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Zavation — ZAVATION · Class II
- STARDRIVE — Synthes GmbH · Class IIb
- Arthrex® — Arthrex, Inc. · Class II
- Cancellous Screw, Locking — I.T.S. GmbH · Class II
- PANGEA — Stryker Corp. · Class II
Cleared under the same submission
K153338 also covers:
- 0.035" x 5" K-Wire Standard — Trilliant Surgical LLC
- 0.045" x 6" K-Wire Standard — Trilliant Surgical LLC
- Tiger — Trilliant Surgical LLC
- Tiger — Trilliant Surgical LLC
- Tiger — Trilliant Surgical LLC
- Tiger — Trilliant Surgical LLC
- Tiger — Trilliant Surgical LLC
- Tiger — Trilliant Surgical LLC
- Tiger — Trilliant Surgical LLC
- Tiger — Trilliant Surgical LLC
- Tiger — Trilliant Surgical LLC
- Tiger — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Trilliant Surgical LLC
Sources (1)
- FDA UDI 59007dd9-a999-4527-848a-8211605192e3 34 fields · synced May 30, 2026