Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013462427

FEI Number

3013462427

Entity Name

NanoHive Medical LLC

City/State/Country

Woburn, MA, US

Establishment Address

12 Gill St, Suite 4500, Woburn, MA 01801, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

NanoHive Medical (Owner Number: 10055679)

Owner / Operator Contact Address

12 Gill St, Suite 4500, Woburn, MA 01801, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hive Standalone ALIF System Hive AL Interbody System Hive C Interbody System Hive Standalone Cervical System Hive TL Interbody System Hive O-AL Interbody System Hive PL Interbody System NanoHive Medical Lumbar Interbody System TLIF Hive-T Curved Interbody Spacer Hive PL Interbody System TLIF Hive-T Interbody Spacer Hive AL Interbody System ALIF Hive-A Interbody Spacer Hive TL Interbody System PLIF Hive-P Interbody Spacer Hive O-AL Interbody System Hive Standalone Cervical System Hive O-AL Interbody System Hive PL Interbody System Hive TL Interbody System Hive AL Interbody System NanoHive Medical Lumbar Interbody System Mallet Hive C Interbody System Hive Standalone Cervical System Drill Guide Hive Standalone ALIF System Hive Standalone Cervical System Hive Standalone ALIF System Hive Standalone Cervical System impactor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-02-20
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2017-09-12
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2023-01-18
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2023-01-18
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-08-08
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2026-05-08
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2026-05-04
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2026-05-04
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-02-26
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2024-02-20
HWA	Impactor	Orthopedic	Class 1	888.4540	2017-09-12

Official Correspondent

Christy Rickrode

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NanoHive Medical

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05
K193541	Nu Vasive, Incorporated	NuVasive Cohere Thoracolumbar Interbody System	2020-03-30
K080401	Advanced Medical Technologies AG	SHELL CAGE, WAVE CAGE, LOOP CAGE	2008-05-09
K200084	Zavation Medical Products, LLC	Zavation IBF System	2020-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0010-2008	N/A	1	EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013462427. Last updated year: 2026. Please use registration number 3013462427 when referencing this establishment in official correspondence.