Identity
- Trade Name
- ODI 7.0mm Cannulated Screw System FDA UDI
- Generic Name
- Implantable bone washer FDA UDI
- Device Name
- Washer FDA UDI
- Model / Reference
- CSS001137 FDA UDI
- Description
- Washer FDA UDI
Identifiers
- Primary DI / UDI-DI
- B058CSS0011371 FDA UDI
- 510(k) Number
- K030619 FDA UDI
- FDA Product Code
- HTN FDA UDI
- GMDN Term
- Implantable bone washer 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
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 13 Millimeter FDA UDILumen/Inner Diameter — 7.2 Millimeter FDA UDI
Category: Implantable bone washer
ODI 7.0mm Cannulated Screw System by Orthopedic Designs North America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Implantable bone washer.
- ISOLA — Depuy Spine, Inc. · Class II
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- Monster Screw System — Paragon 28 · Class II
- ALPHALOK Plating System — Vilex, Inc. · Class II
- Monster Screw System — Paragon 28 · Class II
- FLAT WASHER — Biomet Orthopedics, Inc. · Class II
- Fixcet Spinal Facet Screw System — Xtant Medical Holdings, Inc. · U
- LEOS Cannulated Screw System — Tyber Medical · Class II
Cleared under the same submission
K030619 also covers:
- ODI 7.0mm Cannulated Screw System — Orthopedic Designs North America, Inc.
- ODI 7.0mm Cannulated Screw System — Orthopedic Designs North America, Inc.
- ODI 7.0mm Cannulated Screw System — Orthopedic Designs North America, Inc.
- ODI 7.0mm Cannulated Screw System — Orthopedic Designs North America, Inc.
- ODI 7.0mm Cannulated Screw System — Orthopedic Designs North America, Inc.
- ODI 7.0mm Cannulated Screw System — Orthopedic Designs North America, Inc.
- ODI 7.0mm Cannulated Screw System — Orthopedic Designs North America, Inc.
- ODI 7.0mm Cannulated Screw System — Orthopedic Designs North America, Inc.
- ODI 7.0mm Cannulated Screw System — Orthopedic Designs North America, Inc.
- ODI 7.0mm Cannulated Screw System — Orthopedic Designs North America, Inc.
- ODI 7.0mm Cannulated Screw System — Orthopedic Designs North America, Inc.
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
- Orthopedic Designs North America, Inc.
Sources (1)
- FDA UDI 1a890b92-a053-4e69-910d-f0ab1914e994 36 fields · synced May 30, 2026