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Hive™ Standalone Cervical System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K223190

by NanoHive Medical LLC

Identity

Trade Name
Hive Standalone Cervical System FDA UDI
Generic Name
Metallic spinal interbody fusion cage FDA UDI
Device Name
18Wx14Lx10H, 6° Zero Profile - Tube Package Configuration FDA UDI
Model / Reference
08-A-2006-4010 FDA UDI
Description
18Wx14Lx10H, 6° Zero Profile - Tube Package Configuration FDA UDI

Identifiers

Catalog Number
08-A-2006-4010 FDA UDI
Primary DI / UDI-DI
00817493024969 FDA UDI
510(k) Number
K223190 FDA 510(k)FDA UDI
FDA Product Code
OVE FDA 510(k)FDA UDI
ODP FDA UDI
GMDN Term
Metallic spinal interbody fusion cage FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 888.3080 FDA 510(k)
Regulation Number
888.3080 FDA 510(k)FDA UDI
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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
Width — 18 Millimeter FDA UDI
Length — 14 Millimeter FDA UDI
Height — 10 Millimeter FDA UDI
Angle — 6 degree FDA UDI

Hive™ Standalone Cervical System by NanoHive Medical LLC — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
NanoHive Medical LLC
FDA Applicant
NanoHive Medical, LLC

Sources (2)

  • FDA 510(k) K223190 24 fields · synced Jun 19, 2026
  • FDA UDI 494fffb7-c2fe-48f6-9010-79afc513d8a7 37 fields · synced May 27, 2026