FDA.report

510(k) K170676

Device
HD Lumbar Interbody System
Applicant
HD LifeSciences LLC
510(k) number
K170676
Product code
MAX  
Decision
Substantially Equivalent (SESE)
Decision date
2017-07-13
Date received
2017-03-06
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Bone Graft, Lumbar
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Ian Helmar
Address
38 Montvale Ave. Suite 380 Stoneham MA US 02180 02180

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
00817493025676Hive PL Interbody SystemNanohive Medical LLC2023-09-11
00817493025713Hive PL Interbody SystemNanohive Medical LLC2023-09-11
00817493025690Hive PL Interbody SystemNanohive Medical LLC2023-09-11
00817493025652Hive PL Interbody SystemNanohive Medical LLC2023-09-11
00817493025706Hive PL Interbody SystemNanohive Medical LLC2023-09-11
00817493025683Hive PL Interbody SystemNanohive Medical LLC2023-09-11
00817493021494Hive PL Interbody SystemNanohive Medical LLC2023-09-11
00817493025669Hive PL Interbody SystemNanohive Medical LLC2023-09-11
00817493026369Hive TL Interbody SystemNanohive Medical LLC2023-09-08
00817493026390Hive TL Interbody SystemNanohive Medical LLC2023-09-08
00817493026437Hive PL Interbody SystemNanohive Medical LLC2023-09-08
00817493026383Hive TL Interbody SystemNanohive Medical LLC2023-09-08
00817493026413Hive TL Interbody SystemNanohive Medical LLC2023-09-08
00817493026420Hive PL Interbody SystemNanohive Medical LLC2023-09-08
00817493026338Hive TL Interbody SystemNanohive Medical LLC2023-09-08
00817493026376Hive TL Interbody SystemNanohive Medical LLC2023-09-08
00817493026352Hive TL Interbody SystemNanohive Medical LLC2023-09-08
00817493026406Hive TL Interbody SystemNanohive Medical LLC2023-09-08
00817493026345Hive TL Interbody SystemNanohive Medical LLC2023-09-08
00817493025607Hive PL Interbody SystemNanohive Medical LLC2023-08-29
00817493025577Hive PL Interbody SystemNanohive Medical LLC2023-08-29
00817493025737Hive PL Interbody SystemNanohive Medical LLC2023-08-29
00817493025553Hive PL Interbody SystemNanohive Medical LLC2023-08-29
00817493025591Hive PL Interbody SystemNanohive Medical LLC2023-08-29
00817493025560Hive PL Interbody SystemNanohive Medical LLC2023-08-29
00817493021487Hive PL Interbody SystemNanohive Medical LLC2023-08-29
00817493026130Hive PL Interbody SystemNanohive Medical LLC2023-08-29
00817493025720Hive PL Interbody SystemNanohive Medical LLC2023-08-29
00817493026123Hive PL Interbody SystemNanohive Medical LLC2023-08-29
00817493026086Hive PL Interbody SystemNanohive Medical LLC2023-08-29

Legacy Summary

summary

FDA Review

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases