Identity
- Trade Name
- WAVE D SPINAL SYSTEM FDA UDI
- Generic Name
- Bone graft funnel FDA UDI
- Device Name
- FUNNEL 2670007 WAVE FUNNEL FDA UDI
- Model / Reference
- 2670007 FDA UDI
- Description
- FUNNEL 2670007 WAVE FUNNEL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169245044 FDA UDI
- 510(k) Number
- K121333 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Bone graft funnel 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
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
Category: Bone graft funnel
Wave D Spinal System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone graft funnel.
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- HiJAK™ Cervical — ATLAS SPINE INC. · Class II
- KOHDENT — Kohler Medizintechnik GmbH & Co. KG · Class I
- EquiLOX Lumbar Expandable Cage - Bone Graft Funnel — Captiva Spine · Class I
- Solus — ALPHATEC SPINE, INC. · Class I
- Life Instruments — Life Instrument Corporation · Class I
- Axis Spine Technologies ALIF System Instrument — AXIS SPINE TECHNOLOGIES LTD · Class II
- Tranquil-L™ — NEXUS SPINE, L.L.C. · Class I
Cleared under the same submission
K121333 also covers:
- WAVE D SPINAL SYSTEM — MEDTRONIC SOFAMOR DANEK, INC.
- WAVE D SPINAL SYSTEM — MEDTRONIC SOFAMOR DANEK, INC.
- WAVE D SPINAL SYSTEM — MEDTRONIC SOFAMOR DANEK, INC.
- WAVE D SPINAL SYSTEM — MEDTRONIC SOFAMOR DANEK, INC.
- WAVE D SPINAL SYSTEM — MEDTRONIC SOFAMOR DANEK, INC.
- WAVE D SPINAL SYSTEM — MEDTRONIC SOFAMOR DANEK, INC.
- WAVE D SPINAL SYSTEM — MEDTRONIC SOFAMOR DANEK, INC.
- WAVE D SPINAL SYSTEM — MEDTRONIC SOFAMOR DANEK, INC.
- WAVE D SPINAL SYSTEM — MEDTRONIC SOFAMOR DANEK, INC.
- WAVE D SPINAL SYSTEM — MEDTRONIC SOFAMOR DANEK, INC.
- WAVE D SPINAL SYSTEM — MEDTRONIC SOFAMOR DANEK, INC.
- WAVE D SPINAL SYSTEM — MEDTRONIC SOFAMOR DANEK, 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
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI 60e6e593-dfce-4924-844d-28165363e019 35 fields · synced Jun 1, 2026