Identity
- Trade Name
- Lumbar Interbody Fusion System (OLLIF) FDA UDI
- Generic Name
- Bone curette, single-use FDA UDI
- Device Name
- Lumbar Interbody Fusion System (OLLIF) Flexible Curette Loop Blade FDA UDI
- Model / Reference
- 01-06-4 FDA UDI
- Description
- Lumbar Interbody Fusion System (OLLIF) Flexible Curette Loop Blade FDA UDI
Identifiers
- Catalog Number
- 01-06-4 FDA UDI
- Primary DI / UDI-DI
- 00850014575311 FDA UDI
- 510(k) Number
- K173947 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Bone curette, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone curette, single-use
Lumbar Interbody Fusion System (OLLIF) by Advanced Research Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone curette, single-use.
- MACI Arthroscopic Instruments — Vericel Corporation · Class I
- Neo Medical Cage kit — Neo Medical Inc. · Class I
- CURRETTE — DR.FRIGZ INTERNATIONAL(PVT)LTD, · Class I
- Instrapac — ROBINSON HEALTHCARE LIMITED · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Instrapac — ROBINSON HEALTHCARE LIMITED · Class I
- MACI Arthroscopic Instruments — Vericel Corporation · Class I
- Neo Medical Cage kit — Neo Medical Inc. · Class I
Cleared under the same submission
K173947 also covers:
- Lumbar Interbody Fusion System (OLLIF) — ADVANCED RESEARCH MEDICAL LLC
- Lumbar Interbody Fusion System (OLLIF) — ADVANCED RESEARCH MEDICAL LLC
- Lumbar Interbody Fusion System (OLLIF) — ADVANCED RESEARCH MEDICAL LLC
- Lumbar Interbody Fusion System (OLLIF) — ADVANCED RESEARCH MEDICAL LLC
- Lumbar Interbody Fusion System (OLLIF) — ADVANCED RESEARCH MEDICAL LLC
- Lumbar Interbody Fusion System (OLLIF) — ADVANCED RESEARCH MEDICAL LLC
- Lumbar Interbody Fusion System (OLLIF) — ADVANCED RESEARCH MEDICAL LLC
- Lumbar Interbody Fusion System (OLLIF) — ADVANCED RESEARCH MEDICAL LLC
- Lumbar Interbody Fusion System (OLLIF) — ADVANCED RESEARCH MEDICAL LLC
- Lumbar Interbody Fusion System (OLLIF) — ADVANCED RESEARCH MEDICAL LLC
- Lumbar Interbody Fusion System (OLLIF) — ADVANCED RESEARCH MEDICAL LLC
- Lumbar Interbody Fusion System (OLLIF) — ADVANCED RESEARCH MEDICAL LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advanced Research Medical Llc
Sources (1)
- FDA UDI b0c662b7-7c5c-4300-8fc7-76100713845e 36 fields · synced May 30, 2026