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Hive Standalone Cervical System

FDA UDI

Class II (US FDA UDI)

by NanoHive Medical LLC

Identity

Trade Name
Hive Standalone Cervical System FDA UDI
Generic Name
Metallic spinal interbody fusion cage FDA UDI
Device Name
15Wx12Lx7H, 6° Zero Profile - Tube Package Configuration FDA UDI
Model / Reference
08-A-2001-4007 FDA UDI
Description
15Wx12Lx7H, 6° Zero Profile - Tube Package Configuration FDA UDI

Identifiers

Catalog Number
08-A-2001-4007 FDA UDI
Primary DI / UDI-DI
00817493024792 FDA UDI
510(k) Number
K223190 FDA UDI
FDA Product Code
ODP FDA UDI
OVE FDA UDI
GMDN Term
Metallic spinal interbody fusion cage 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Angle — 6 degree FDA UDI
Width — 15 Millimeter FDA UDI
Length — 12 Millimeter FDA UDI
Height — 7 Millimeter FDA UDI

Category: Metallic spinal interbody fusion cage

Hive Standalone Cervical System by NanoHive Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metallic spinal interbody fusion cage.

Cleared under the same submission

K223190 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
NanoHive Medical LLC

Sources (1)

  • FDA UDI d7b3dfff-0813-4565-a7ab-9bc4e181734e 37 fields · synced Jun 1, 2026