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Syntec-Taichung Non-sterile Bone Plate and Screw Implants
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Syntec-Taichung Non-sterile Bone Plate and Screw Implants FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- Straight Reconstruction Plate 3.5x 20Holes x L238mm FDA UDI
- Model / Reference
- 245100 FDA UDI
- Description
- Straight Reconstruction Plate 3.5x 20Holes x L238mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719864684672 FDA UDI
- 510(k) Number
- K983495 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Syntec-Taichung Non-sterile Bone Plate and Screw Implants by Syntec Scientific Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable, non-sterile.
- CANNULATED SCREW SYSTEM — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- Proximal Humeral Locking Plate Ⅱ, Combi-holes — Double Medical Technology Inc. · Class II
- ORTHOLOC — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- Summa Orthopaedics Wrist System Bone Plate — Jeil Medical Corporation · Class II
- Summa Orthopaedics Foot System Bone Plate — Jeil Medical Corporation · Class II
- SAMPEDRO — Industrias Medicas Sampedro S.A.S · Class II
- TUBULAR PLATE — Biomet Orthopedics, Inc. · Class II
- APTUS — Medartis Inc. · Class II
Cleared under the same submission
K983495 also covers:
- Syntec-Taichung Non-sterile Bone Plate and Screw Implants — Syntec Scientific Corp.
- Syntec-Taichung Non-sterile Bone Plate and Screw Implants — Syntec Scientific Corp.
- Syntec-Taichung Non-sterile Bone Plate and Screw Implants — Syntec Scientific Corp.
- Syntec-Taichung Non-sterile Bone Plate and Screw Implants — Syntec Scientific Corp.
- Syntec-Taichung Non-sterile Bone Plate and Screw Implants — Syntec Scientific Corp.
- Syntec-Taichung Non-sterile Bone Plate and Screw Implants — Syntec Scientific Corp.
- Syntec-Taichung Non-sterile Bone Plate and Screw Implants — Syntec Scientific Corp.
- Syntec-Taichung Non-sterile Bone Plate and Screw Implants — Syntec Scientific Corp.
- Syntec-Taichung Non-sterile Bone Plate and Screw Implants — Syntec Scientific Corp.
- Syntec-Taichung Non-sterile Bone Plate and Screw Implants — Syntec Scientific Corp.
- Syntec-Taichung Non-sterile Bone Plate and Screw Implants — Syntec Scientific Corp.
- Syntec-Taichung Non-sterile Bone Plate and Screw Implants — Syntec Scientific Corp.
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
- Syntec Scientific Corp.
Sources (1)
- FDA UDI 9def933b-afbc-4ebd-9d25-a9b4b5e83790 34 fields · synced Jun 8, 2026