Identity
- Trade Name
- ATEC Lateral Navigation Disc Prep Instruments FDA UDI
- Generic Name
- Fascial tissue dilator, single-use FDA UDI
- Device Name
- LIF Nav Primary Dilator Stimulating FDA UDI
- Model / Reference
- 266-00-100-N FDA UDI
- Description
- LIF Nav Primary Dilator Stimulating FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190376476131 FDA UDI
- 510(k) Number
- K223765 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Fascial tissue dilator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 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: Fascial tissue dilator, single-use
ATEC Lateral Navigation Disc Prep Instruments by Alphatec Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fascial tissue dilator, single-use.
- Byrd — COOK VANDERGRIFT INC. · Class I
- Cook — COOK INCORPORATED · Class II
- Cook — COOK INCORPORATED · Class II
- Dilator — GALT MEDICAL CORP. · Class IIa
- VisiSheath Dilator Sheath — Spectranetics Corporation · Class III
- Dilator — GALT MEDICAL CORP. · Class IIa
- Cook — COOK INCORPORATED · Class II
- Cook — COOK INCORPORATED · Class II
Cleared under the same submission
K223765 also covers:
- ATEC Lateral Navigation Disc Prep Instruments — ALPHATEC SPINE, INC.
- ATEC Lateral Navigation Disc Prep Instruments — ALPHATEC SPINE, INC.
- ATEC Lateral Navigation Disc Prep Instruments — ALPHATEC SPINE, INC.
- ATEC Lateral Navigation Disc Prep Instruments — ALPHATEC SPINE, INC.
- ATEC Lateral Navigation Disc Prep Instruments — ALPHATEC SPINE, INC.
- ATEC Lateral Navigation Disc Prep Instruments — ALPHATEC SPINE, INC.
- ATEC Lateral Navigation Disc Prep Instruments — ALPHATEC SPINE, INC.
- ATEC Lateral Navigation Disc Prep Instruments — ALPHATEC SPINE, INC.
- ATEC Lateral Navigation Disc Prep Instruments — ALPHATEC SPINE, INC.
- ATEC Lateral Navigation Disc Prep Instruments — ALPHATEC SPINE, INC.
- ATEC Lateral Navigation Disc Prep Instruments — ALPHATEC SPINE, INC.
- ATEC Lateral Navigation Disc Prep Instruments — ALPHATEC 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
- Alphatec Spine, Inc.
Sources (1)
- FDA UDI b3fb99ae-74b5-4768-80ab-d15a9a3e1092 35 fields · synced Jun 8, 2026