FDA.reportPublic FDA data

Hive Standalone Cervical System

Primary DI
00817493027793
Brand
Hive Standalone Cervical System
Company
Nanohive Medical LLC
Model
08-A-1000-3018
Catalog number
08-A-1000-3018
Device description
CSA ANCHOR, 18L, 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
00817493027793PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817493027793008174930277938174930277930817493027793

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
Length18Millimeter
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
00817493027786Hive Standalone Cervical System08-A-1000-301608-A-1000-30162026-05-08
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
00810017915125SABER-XA, Screw Ø5.0 x 22.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915125SABER-XA, Screw Ø5.0 x 22.5ELEVATION SPINE, INC.OVE2026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5ELEVATION SPINE, INC.OVE2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.OVE2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.OVE2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.ODP2026-09-22
10888857461819CASCADIA™ Interbody SystemVB Spine LLCODP2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCODP2019-10-31
04546540679147AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679154AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679161AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679178AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679185AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679192AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679208AVS Anchor-CStryker CorporationOVE2016-09-24
07613252602774AVS Anchor-LStryker CorporationODP2016-09-24
07613252602781AVS Anchor-LStryker CorporationODP2016-09-24
07613252602798AVS Anchor-LStryker CorporationODP2016-09-24
07613252602804AVS Anchor-LStryker CorporationODP2016-09-24
07613252602811AVS Anchor-LStryker CorporationODP2016-09-24
07613252602828AVS Anchor-LStryker CorporationODP2016-09-24
07613252602835AVS Anchor-LStryker CorporationODP2016-09-24
07613252603283AVS Anchor-LStryker CorporationODP2016-09-24
07613252711599AVS Anchor-CStryker CorporationOVE2016-09-24
07613252711605AVS Anchor-CStryker CorporationOVE2016-09-24
07613252711612AVS Anchor-CStryker CorporationOVE2016-09-24
07613252711629AVS Anchor-CStryker CorporationOVE2016-09-24
07613252711636AVS Anchor-CStryker CorporationOVE2016-09-24