Identity
- Trade Name
- AVATAR Minimally Invasive Spinal System FDA UDI
- Generic Name
- Endoscopic-access dilator, reusable FDA UDI
- Device Name
- #4 Dialation Tube, Stainless Steel FDA UDI
- Model / Reference
- 117-313 FDA UDI
- Description
- #4 Dialation Tube, Stainless Steel FDA UDI
Identifiers
- Catalog Number
- 117-313 FDA UDI
- Primary DI / UDI-DI
- 00190837053666 FDA UDI
- 510(k) Number
- K111953 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Endoscopic-access dilator, 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
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
AVATAR Minimally Invasive Spinal System by Life Spine, Inc. — Class II — 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
K111953 also covers:
- AVATAR Minimally Invasive Spinal System — Life Spine, Inc.
- AVATAR Minimally Invasive Spinal System — Life Spine, Inc.
- AVATAR Minimally Invasive Spinal System — Life Spine, Inc.
- AVATAR Minimally Invasive Spinal System — Life Spine, Inc.
- AVATAR Minimally Invasive Spinal System — Life Spine, Inc.
- AVATAR Minimally Invasive Spinal System — Life Spine, Inc.
- AVATAR Minimally Invasive Spinal System — Life Spine, Inc.
- AVATAR Minimally Invasive Spinal System — Life Spine, Inc.
- AVATAR Minimally Invasive Spinal System — Life Spine, Inc.
- AVATAR Minimally Invasive Spinal System — Life Spine, Inc.
- AVATAR Minimally Invasive Spinal System — Life Spine, Inc.
- AVATAR Minimally Invasive 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 II | Pending data |
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Manufacturer
- Manufacturer
- Life Spine, Inc.
Sources (1)
- FDA UDI 88d23e4a-db40-42d6-b338-04a4baf1d88a 35 fields · synced Jun 8, 2026