Identity
- Trade Name
- Syntec Osteo-plate and screw Fixation FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- Cortex Screw Self-Tappingφ3.5 x L10mm FDA UDI
- Model / Reference
- 204810 FDA UDI
- Description
- Cortex Screw Self-Tappingφ3.5 x L10mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04712782854189 FDA UDI
- 510(k) Number
- K092889 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Syntec Osteo-plate and screw fixation device is a non-bioabsorbable, non-sterile orthopaedic bone screw used for internal orthopedic fracture fixation. It features a cortex screw self-tapping design with a slotted head, suitable for various applications including orthopedic implants.
Similar devices
Also classified as Orthopaedic bone screw, non-bioabsorbable, non-sterile.
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- Monster Screw System — Paragon 28 · Class II
- AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 75mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- APTUS — Medartis Inc. · Class II
- SMOOTH PEG — Biomet Orthopedics, Inc. · Class II
- AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 105mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- QWIX — Newdeal Sas · Class II
- Monster Screw System — Paragon 28 · Class II
Cleared under the same submission
K092889 also covers:
- Syntec Osteo-plate and screw Fixation — Syntec Scientific Corp.
- Syntec Osteo-plate and screw Fixation — Syntec Scientific Corp.
- Syntec Osteo-plate and screw Fixation — Syntec Scientific Corp.
- Syntec Osteo-plate and screw Fixation — Syntec Scientific Corp.
- Syntec Osteo-plate and screw Fixation — Syntec Scientific Corp.
- Syntec Osteo-plate and screw Fixation — Syntec Scientific Corp.
- Syntec Osteo-plate and screw Fixation — Syntec Scientific Corp.
- Syntec Osteo-plate and screw Fixation — Syntec Scientific Corp.
- Syntec Osteo-plate and screw Fixation — Syntec Scientific Corp.
- Syntec Osteo-plate and screw Fixation — Syntec Scientific Corp.
- Syntec Osteo-plate and screw Fixation — Syntec Scientific Corp.
- Syntec Osteo-plate and screw Fixation — Syntec Scientific Corp.
Authorization Coverage (1 country)
Regulatory Authorizations
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 24a962ae-a52f-40df-a1d9-77bda33c3d09 34 fields · synced Jun 19, 2026