Identity
- Trade Name
- FS3 Facet Screw Spinal System FDA UDI
- Generic Name
- Endoscopic-access dilator, reusable FDA UDI
- Device Name
- DILATION TUBE 4 FDA UDI
- Model / Reference
- 117-320 FDA UDI
- Description
- DILATION TUBE 4 FDA UDI
Identifiers
- Catalog Number
- 117-320 FDA UDI
- Primary DI / UDI-DI
- 00190837041151 FDA UDI
- 510(k) Number
- K090865 FDA UDI
- FDA Product Code
- MRW FDA UDI
- GMDN Term
- Endoscopic-access dilator, reusable FDA UDI
Classification
- Device Class
- U 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: Endoscopic-access dilator, reusable
FS3 Facet Screw Spinal System by Life Spine, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic-access dilator, reusable.
- Target Endoscopic Instrument — SOLENDOS Inc. · Class I
- Percutaneous Nephrostomy Dilator — Well Lead Medical Co., Ltd · Class I
- Arthrex® — Arthrex, Inc. · Class I
- iLESSYS® — JOIMAX, INC. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- TESSYS® — JOIMAX, INC. · Class I
- T-FIX™3Dsi Joint Fusion System — CUTTING EDGE SPINE · Class II
- MaxMoreSpine — Hoogland Spine Products, GmbH · Class I
Cleared under the same submission
K090865 also covers:
- FS3 — Life Spine, Inc.
- FS3 Facet Screw Spinal System — Life Spine, Inc.
- FS3 Facet Screw Spinal System — Life Spine, Inc.
- FS3 Facet Screw Spinal System — Life Spine, Inc.
- FS3 Facet Screw Spinal System — Life Spine, Inc.
- FS3 Facet Screw Spinal System — Life Spine, Inc.
- FS3 Facet Screw Spinal System — Life Spine, Inc.
- FS3 Facet Screw Spinal System — Life Spine, Inc.
- FS3 Facet Screw Spinal System — Life Spine, Inc.
- FS3 Facet Screw Spinal System — Life Spine, Inc.
- FS3 Facet Screw Spinal System — Life Spine, Inc.
- FS3 Facet Screw Spinal System — Life Spine, 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 U | Pending data |
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Manufacturer
- Manufacturer
- Life Spine, Inc.
Sources (1)
- FDA UDI 408ee2db-6c71-44d5-8dde-65d3405349a0 35 fields · synced May 30, 2026