Identity
- Trade Name
- Sniper® Spine System FDA UDI
- Generic Name
- Orthopaedic implantation sleeve, reusable FDA UDI
- Device Name
- Screw Extension, Outer Sleeve FDA UDI
- Model / Reference
- 10-4100.1 FDA UDI
- Description
- Screw Extension, Outer Sleeve FDA UDI
Identifiers
- Catalog Number
- 10-4100.1 FDA UDI
- Primary DI / UDI-DI
- 10840642108101 FDA UDI
- 510(k) Number
- K100605 FDA UDI
- FDA Product Code
- MNH FDA UDI
- GMDN Term
- Orthopaedic implantation sleeve, 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: Orthopaedic implantation sleeve, 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 Orthopaedic implantation sleeve, reusable.
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- RIGID SUPRA ENTRY SLEEVE 13MM — Zimmer, Inc. · Class I
- Jet-X — Smith & Nephew, Inc. · Class II
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- SOFT TISSUE PROTECTOR HUDSON QUICK CONNECT — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
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 66c7bc4d-035c-415a-bad9-0d66eb350bd2 36 fields · synced May 30, 2026