Identity
- Trade Name
- NanoHive IBFD FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- Lumbar Inserter, Short, Shaft FDA UDI
- Model / Reference
- L-C-0005 FDA UDI
- Description
- Lumbar Inserter, Short, Shaft FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817493021081 FDA UDI
- 510(k) Number
- K170676 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, 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
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: Orthopaedic inorganic implant inserter/extractor, reusable
NanoHive IBFD by NanoHive Medical LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic inorganic implant inserter/extractor, reusable.
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Cleared under the same submission
K170676 also covers:
- Hive PL Interbody System — NanoHive Medical LLC
- Hive PL Interbody System — NanoHive Medical LLC
- Hive PL Interbody System — NanoHive Medical LLC
- Hive PL Interbody System — NanoHive Medical LLC
- Hive PL Interbody System — NanoHive Medical LLC
- Hive PL Interbody System — NanoHive Medical LLC
- Hive PL Interbody System — NanoHive Medical LLC
- Hive PL Interbody System — NanoHive Medical LLC
- Hive PL Interbody System — NanoHive Medical LLC
- Hive PL 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 I | Pending data |
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Manufacturer
- Manufacturer
- NanoHive Medical LLC
Sources (1)
- FDA UDI d1ab2cc7-07ba-47f5-a434-661e561a6dfa 35 fields · synced Jun 1, 2026