Cannulated Headless Compression Screw, 1/4 Threaded, 3.5mm x 26mm
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Headless Cannulated Compression Screw 3.5 mm X 26 mm EUDAMEDCannulated Headless Compression Screw, 1/4 Threaded, 3.5mm x 26mm FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- Headless Cannulated Compression Screw 3.5 mm X 26 mm EUDAMED
- Model / Reference
- PNM2014-026 EUDAMED8080-026 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08680487058170 EUDAMED00848665024913 FDA UDI
- Basic UDI-DI
- B-08680487058170 EUDAMED
- 510(k) Number
- K152732 FDA UDI
- FDA Product Code
- HWC FDA UDI
- EMDN Code
- P09120603 CANNULATED SCREWS EUDAMED
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Market of Registration
- Türkiye EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
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
Yes
Manufacturing Date
No
Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile
Cannulated Headless Compression Screw, 1/4 Threaded, 3.5mm x 26mm by Advanced Orthopaedic Solutions, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID…
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Cleared under the same submission
K152732 also covers:
- 2.7mm Calibrated Drill — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS Cannulated Drill, 2.75mm, Ankle Plate — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS DRILL, Ø2.8mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- Anterolateral Distal Tibia Plate, Right, Long, 23-Hole — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- Anterolateral Distal Tibia Plate, Right, Short, 15-Hole — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 36mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 40mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 46mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 50mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- Cannulated Headless Compression Screw, 1/4 Threaded, 3.5mm x 20mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- Cannulated Headless Compression Screw, 1/4 Threaded, 3.5mm x 34mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- Cannulated Headless Compression Screw, 1/4 Threaded, 3.5mm x 65mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Advanced Orthopaedic Solutions, Inc.
Sources (2)
- FDA UDI 62957822-4f84-4fcf-a18f-39290499b1b5 33 fields · synced Jul 11, 2026
- EUDAMED 8218f57b-056e-4f2b-8fdb-94c75ce30b3a 61 fields · synced Jul 11, 2026