Identity
- Trade Name
- Aries-L Lateral Lumbar Interbody System FDA UDI
- Generic Name
- Bone file/rasp, manual, reusable FDA UDI
- Device Name
- 12mm Paddle Shaver Lateral FDA UDI
- Model / Reference
- 1450-8012 FDA UDI
- Description
- 12mm Paddle Shaver Lateral FDA UDI
Identifiers
- Catalog Number
- 1450-8012 FDA UDI
- Primary DI / UDI-DI
- B06214508012 FDA UDI
- 510(k) Number
- K181347 FDA UDI
- FDA Product Code
- HWM FDA UDI
- GMDN Term
- Bone file/rasp, manual, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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: Bone file/rasp, manual, reusable
Aries-L Lateral Lumbar Interbody System by Osseus Fusion Systems Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K181347 also covers:
- Aries-L Lateral Lumbar Interbody System — OSSEUS FUSION SYSTEMS LLC
- Aries-L Lateral Lumbar Interbody System — OSSEUS FUSION SYSTEMS LLC
- Aries-L Lateral Lumbar Interbody System — OSSEUS FUSION SYSTEMS LLC
- Aries-L Lateral Lumbar Interbody System — OSSEUS FUSION SYSTEMS LLC
- Aries-L Lateral Lumbar Interbody System — OSSEUS FUSION SYSTEMS LLC
- Aries-L Lateral Lumbar Interbody System — OSSEUS FUSION SYSTEMS LLC
- Aries-L Lateral Lumbar Interbody System — OSSEUS FUSION SYSTEMS LLC
- Aries-L Lateral Lumbar Interbody System — OSSEUS FUSION SYSTEMS LLC
- Aries-L Lateral Lumbar Interbody System — OSSEUS FUSION SYSTEMS LLC
- Aries-L Lateral Lumbar Interbody System — OSSEUS FUSION SYSTEMS LLC
- Aries-L Lateral Lumbar Interbody System — OSSEUS FUSION SYSTEMS LLC
- Aries-L Lateral Lumbar Interbody System — OSSEUS FUSION SYSTEMS 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 I | Pending data |
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Manufacturer
- Manufacturer
- Osseus Fusion Systems Llc
Sources (1)
- FDA UDI 18da267a-0b82-467e-b85a-510b80a67ab9 35 fields · synced May 30, 2026