FDA.report

Hive Standalone ALIF System

Primary DI
00817493023917
Brand
Hive Standalone ALIF System
Company
Nanohive Medical LLC
Model
06-A-0004-4013
Catalog number
06-A-0004-4013
Device description
32W x 26L x 13H, 15° - Peel Pouch Packaging Configuration
Published
2023-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions

SubmissionSupplement
K200541000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K200541000Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC2020-04-28OVD

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817493023917PrimaryGS10

GMDN Terms

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 in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical 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 included with the device.

Device Sizes

TypeValueUnit
Angle15degree
Height13Millimeter
Length26Millimeter
Width32Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
844-943-5433customerservice@nanohive.com

Regulatory Flags

DUNS number
080469093
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00817493022026NanoHive General Instruments - ALIFL-A-0011-08112025-09-08
00817493022033NanoHive General Instruments - ALIFL-A-0011-08132025-09-08
00817493022040NanoHive General Instruments - ALIFL-A-0011-08152025-09-08
00817493022057NanoHive General Instruments - ALIFL-A-0011-08172025-09-08
00817493022071NanoHive General Instruments - ALIFL-A-0011-15112025-09-08
00817493022088NanoHive General Instruments - ALIFL-A-0011-15132025-09-08
00817493022095NanoHive General Instruments - ALIFL-A-0011-15152025-09-08
00817493022101NanoHive General Instruments - ALIFL-A-0011-15172025-09-08
00817493022149NanoHive General Instruments - ALIFL-A-0014-08112025-09-08
00817493022156NanoHive General Instruments - ALIFL-A-0014-08132025-09-08
00817493022163NanoHive General Instruments - ALIFL-A-0014-08152025-09-08
00817493022170NanoHive General Instruments - ALIFL-A-0014-08172025-09-08
00817493022194NanoHive General Instruments - ALIFL-A-0014-15112025-09-08
00817493022200NanoHive General Instruments - ALIFL-A-0014-15132025-09-08
00817493022217NanoHive General Instruments - ALIFL-A-0014-15152025-09-08
00817493022224NanoHive General Instruments - ALIFL-A-0014-15172025-09-08
00817493022231NanoHive General Instruments - ALIFL-A-0014-15192025-09-08
00817493022248NanoHive General Instruments - ALIFL-A-0014-22132025-09-08
00817493022255NanoHive General Instruments - ALIFL-A-0014-22152025-09-08
00817493022262NanoHive General Instruments - ALIFL-A-0014-22172025-09-08

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