Identity
- Trade Name
- NIAGARA® Lateral Access System FDA UDI
- Generic Name
- Surgical retractor/retraction system blade, reusable FDA UDI
- Device Name
- Posterior Blade Size 80 mm FDA UDI
- Model / Reference
- PRO-1099-01 FDA UDI
- Description
- Posterior Blade Size 80 mm FDA UDI
Identifiers
- Catalog Number
- PRO-1099-01 FDA UDI
- Primary DI / UDI-DI
- 10888857530737 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Surgical retractor/retraction system blade, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
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
Dimensions & Sizes
- Size
- Length — 80 Millimeter FDA UDI
Category: Surgical retractor/retraction system blade, reusable
NIAGARA® Lateral Access System by K2m, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical retractor/retraction system blade, reusable.
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- TSI — TEDAN SURGICAL INNOVATIONS, L.L.C. · Class I
- Life Instruments — Life Instrument Corporation · Class I
- Medfix — Medfix International, LLC · Class I
- Specula Retractor Set — Koros USA, Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- K2m, Inc.
Sources (1)
- FDA UDI 73458680-091d-4bd7-aa6c-d26d0e5b0031 36 fields · synced May 30, 2026