FDA.reportPublic FDA data

Hive Standalone Cervical System

Primary DI
00817493027786
Brand
Hive Standalone Cervical System
Company
Nanohive Medical LLC
Model
08-A-1000-3016
Catalog number
08-A-1000-3016
Device description
CSA ANCHOR, 16L, Ø3.0
Published
2026-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K254105000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K254105000Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC2026-02-13ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817493027786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817493027786008174930277868174930277860817493027786

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length16Millimeter
Outer Diameter3Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
844-943-5433customerservice@nanohive.com

Regulatory Flags#

DUNS number
080469093
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817493027779Hive Standalone Cervical System08-A-1000-301408-A-1000-30142026-05-08
00817493027793Hive Standalone Cervical System08-A-1000-301808-A-1000-30182026-05-08
00817493028141Hive Standalone Cervical SystemC-A-1000-0608C-A-1000-06082026-05-08
00817493028158Hive Standalone Cervical SystemC-A-1000-0910C-A-1000-09102026-05-08
00817493028189Hive Standalone Cervical SystemC-A-1002-0608C-A-1002-06082026-05-08
00817493028196Hive Standalone Cervical SystemC-A-1002-0910C-A-1002-09102026-05-08
00817493028219Hive Standalone Cervical SystemC-A-1003C-A-10032026-05-08
00817493028226Hive Standalone Cervical SystemC-A-1004C-A-10042026-05-08
00817493028233Hive Standalone Cervical SystemC-A-1005C-A-10052026-05-08
00817493028240Hive Standalone Cervical SystemC-A-1006C-A-10062026-05-08
00817493028257Hive Standalone Cervical SystemC-A-1007C-A-10072026-05-08
00817493028264Hive Standalone Cervical SystemC-A-1008C-A-10082026-05-08
00817493028271Hive Standalone Cervical SystemC-A-1009C-A-10092026-05-08
00817493028288Hive Standalone Cervical SystemC-A-1010C-A-10102026-05-08
00817493028295Hive Standalone Cervical SystemC-C-1011C-C-10112026-05-08
00817493028301Hive Standalone Cervical SystemC-C-1012C-C-10122026-05-08
00817493021494Hive PL Interbody System03-A-0005-400803-A-0005-40082023-09-11
00817493025652Hive PL Interbody System03-A-0005-400803-A-0005-40082023-09-11
00817493025669Hive PL Interbody System03-A-0005-400903-A-0005-40092023-09-11
00817493025676Hive PL Interbody System03-A-0005-401003-A-0005-40102023-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840311258635C-Plus PEEK IBF SystemXtant Medical Holdings, Inc.ODP2026-08-26
00843511102852Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102869Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102876Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102883Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102890Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102906Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102913Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102920Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00810216325442ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325466ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325800ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325817ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325824ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325831ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325848ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325855ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325862ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325879ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325886ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325893ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325909ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325916ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325923ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325930ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325947ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325954ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325961ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325978ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325985ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17