Identity
- Trade Name
- Odalys FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
- Device Name
- The Odalys is a pedicle screw spinal system. FDA UDI
- Model / Reference
- Polyaxial screw Ø5 L40 FDA UDI
- Description
- The Odalys is a pedicle screw spinal system. FDA UDI
Identifiers
- Catalog Number
- ODPS55540 FDA UDI
- Primary DI / UDI-DI
- 03700406334842 FDA UDI
- 510(k) Number
- K152098 FDA UDI
- FDA Product Code
- MNI FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Bone-screw internal spinal fixation system, non-sterile
Odalys by Kisco International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system, non-sterile.
- TIGER Spine System — CORELINK LLC · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- SILVERTON SPINAL FIXATION SYSTEM — BIOMET SPINE LLC · Class II
- POLARIS™ 5.5 SPINAL SYSTEM — BIOMET SPINE LLC · Class II
- Vitality® — BIOMET SPINE LLC · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- PASS LP — Medicrea International SA · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
Cleared under the same submission
K152098 also covers:
- Odalys — KISCO INTERNATIONAL
- Odalys — KISCO INTERNATIONAL
- Odalys — KISCO INTERNATIONAL
- Odalys — KISCO INTERNATIONAL
- Odalys — KISCO INTERNATIONAL
- Odalys — KISCO INTERNATIONAL
- Odalys — KISCO INTERNATIONAL
- Odalys — KISCO INTERNATIONAL
- Odalys — KISCO INTERNATIONAL
- Odalys — KISCO INTERNATIONAL
- Odalys — KISCO INTERNATIONAL
- Odalys — KISCO INTERNATIONAL
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
- Kisco International
Sources (1)
- FDA UDI e7c3e0f0-3be2-4deb-86ca-19560da133a8 35 fields · synced May 30, 2026