Identity
- Trade Name
- EVOS Lumbar Interbody System FDA UDI
- Generic Name
- Bone file/rasp, manual, reusable FDA UDI
- Device Name
- Bayonet Rake Curette FDA UDI
- Model / Reference
- CES-501 FDA UDI
- Description
- Bayonet Rake Curette FDA UDI
Identifiers
- Catalog Number
- CES-501 FDA UDI
- Primary DI / UDI-DI
- 00841193122083 FDA UDI
- 510(k) Number
- K150321 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Bone file/rasp, manual, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 600 Millimeter FDA UDI
Category: Bone file/rasp, manual, reusable
EVOS Lumbar Interbody System by Cutting Edge Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone file/rasp, manual, reusable.
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Cleared under the same submission
K150321 also covers:
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cutting Edge Spine
Sources (1)
- FDA UDI 6e597198-25c0-42fa-9af6-e9505b6cd7a7 38 fields · synced Jun 8, 2026