Identity
- Trade Name
- WAVE D SPINAL SYSTEM FDA UDI
- Generic Name
- Orthopaedic graft inserter, reusable FDA UDI
- Device Name
- PESTLE 2670008 WAVE PESTLE FDA UDI
- Model / Reference
- 2670008 FDA UDI
- Description
- PESTLE 2670008 WAVE PESTLE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169245051 FDA UDI
- 510(k) Number
- K121333 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Orthopaedic graft inserter, 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
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: Orthopaedic graft inserter, reusable
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 Orthopaedic graft inserter, reusable.
- devemed — devemed GmbH · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Reicodent — devemed GmbH · Class I
- SeaSpine Spacer System - Hollywood — SeaSpine Orthopedics Corporation · Class I
- INTRAFIX — DePuy Mitek, Inc. · Class I
- Zavation — ZAVATION · Class II
- Kalitec Disc Prep — Kalitec Direct LLC · Class I
- Wheelhouse Medical Specials — WHEELHOUSE MEDICAL · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI b1618961-631b-4305-b7b3-9f5a0aa22b8a 35 fields · synced May 30, 2026