FDA.reportPublic FDA data

NanoHive IBFD

Primary DI
00817493021074
Brand
NanoHive IBFD
Company
Nanohive Medical LLC
Model
L-C-0002-01
Device description
Lumbar Inserter, Long, Shaft
Published
2018-08-02
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170676000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170676000HD Lumbar Interbody SystemHd Lifesciences, LLC2017-07-13MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817493021074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817493021074008174930210748174930210740817493021074

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
844-943-5433info@hdlifesciences.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
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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