FDA.reportPublic FDA data

NanoHive General Instruments - Cervical

Primary DI
00817493027090
Brand
NanoHive General Instruments - Cervical
Company
Nanohive Medical LLC
Model
C-A-1512S-0512
Catalog number
C-A-1512S-0512
Device description
Dual Ended Cervical Trials with Stop, 15x12, 12°, 5H and 12H
Published
2025-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817493027090PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817493027090008174930270908174930270900817493027090

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle12degree
Depth12Millimeter
Height5Millimeter
Height12Millimeter
Width15Millimeter

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
Premarket exempt
true
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
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

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