Identity
- Trade Name
- Hive O-AL Interbody System FDA UDI
- Generic Name
- Spinal implant trial FDA UDI
- Device Name
- Hive O-AL Trial, 38W x 34L, 8°, 15H FDA UDI
- Model / Reference
- L-A-0083-0815 FDA UDI
- Description
- Hive O-AL Trial, 38W x 34L, 8°, 15H FDA UDI
Identifiers
- Catalog Number
- L-A-0083-0815 FDA UDI
- Primary DI / UDI-DI
- 00817493027694 FDA UDI
- 510(k) Number
- K231241 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Spinal implant trial 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
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
Dimensions & Sizes
- Size
- Width — 38 Millimeter FDA UDILength — 34 Millimeter FDA UDIAngle — 8 degree FDA UDIHeight — 15 Millimeter FDA UDI
Category: Spinal implant trial
Hive O-AL Interbody System by NanoHive Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K231241 also covers:
- Hive O-AL Interbody System — NanoHive Medical LLC
- Hive O-AL Interbody System — NanoHive Medical LLC
- Hive O-AL Interbody System — NanoHive Medical LLC
- Hive O-AL Interbody System — NanoHive Medical LLC
- Hive O-AL Interbody System — NanoHive Medical LLC
- Hive O-AL Interbody System — NanoHive Medical LLC
- Hive O-AL Interbody System — NanoHive Medical LLC
- Hive O-AL Interbody System — NanoHive Medical LLC
- Hive O-AL Interbody System — NanoHive Medical LLC
- Hive O-AL Interbody System — NanoHive Medical LLC
- Hive PL Interbody System — NanoHive Medical LLC
- Hive PL Interbody System — NanoHive 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 |
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Manufacturer
- Manufacturer
- NanoHive Medical LLC
Sources (1)
- FDA UDI b3b68cd9-fbfd-4df2-8d63-877e1787ccda 37 fields · synced May 31, 2026