Identity
- Trade Name
- Sniper® Spine System FDA UDI
- Generic Name
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
- Device Name
- Rod Introducer FDA UDI
- Model / Reference
- 10-4104 FDA UDI
- Description
- Rod Introducer FDA UDI
Identifiers
- Catalog Number
- 10-4104 FDA UDI
- Primary DI / UDI-DI
- 10840642108132 FDA UDI
- 510(k) Number
- K100605 FDA UDI
- FDA Product Code
- MNH FDA UDI
- GMDN Term
- Surgical implant/trial-implant/sizer holder, reusable 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
Category: Surgical implant/trial-implant/sizer holder, reusable
Sniper® Spine System by Spine Wave, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical implant/trial-implant/sizer holder, reusable.
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- ARx — Life Spine, Inc. · Class II
- APEX 3D Total Ankle Replacement System — Paragon 28 · Class II
- JULIET INSTRUMENTATION — Spineart · Class II
- JOURNEY II XR — Smith & Nephew, Inc. · Class II
- TALOS® (HA) IBF — MEDITECH SPINE, LLC · Class II
- BENCOX THR System — Corentec Co., Ltd · Class II
Cleared under the same submission
K100605 also covers:
- Sniper® Spine System — Spine Wave, Inc.
- Sniper® Spine System — Spine Wave, Inc.
- Sniper® Spine System — Spine Wave, Inc.
- Sniper® Spine System — Spine Wave, Inc.
- Sniper® Spine System — Spine Wave, Inc.
- Sniper® Spine System — Spine Wave, Inc.
- Sniper® Spine System — Spine Wave, Inc.
- Sniper® Spine System — Spine Wave, Inc.
- Sniper® Spine System — Spine Wave, Inc.
- Sniper® Spine System — Spine Wave, Inc.
- Sniper® Spine System — Spine Wave, Inc.
- Sniper® Spine System — Spine Wave, 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
- Spine Wave, Inc.
Sources (1)
- FDA UDI ff95090b-21e8-4ae5-825e-4e8e0422fc68 36 fields · synced May 30, 2026