Identity
- Trade Name
- EVOL®SI Joint Fusion System FDA UDI
- Generic Name
- Bone tap, reusable FDA UDI
- Device Name
- EVOL®SI, 10.5mm Cannulated Tap FDA UDI
- Model / Reference
- CES-315 FDA UDI
- Description
- EVOL®SI, 10.5mm Cannulated Tap FDA UDI
Identifiers
- Catalog Number
- CES-315 FDA UDI
- Primary DI / UDI-DI
- 00841193122526 FDA UDI
- GMDN Term
- Bone tap, reusable FDA UDI
Classification
- 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone tap, reusable
EVOL®SI Joint Fusion System by Cutting Edge Spine — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone tap, reusable.
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- Response 5.5/6.0 Spine System — ORTHOPEDIATRICS CORP. · Class I
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Cutting Edge Spine
Sources (1)
- FDA UDI 18d58acf-1b01-483a-afd9-f0c3213d2a87 36 fields · synced Jun 8, 2026