Hive-T IBFD

GUDID 00817493021340

11W x 32L x 12H Curved TLIF Trial Assembly

HD LIFESCIENCES LLC

Spinal implant trial
Primary Device ID00817493021340
NIH Device Record Key57199b7b-3070-4f11-8186-7c73b97f67d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameHive-T IBFD
Version Model NumberL-A-0024-12
Company DUNS080469093
Company NameHD LIFESCIENCES LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com

Device Dimensions

Height12 Millimeter
Length32 Millimeter
Width11 Millimeter
Height12 Millimeter
Length32 Millimeter
Width11 Millimeter
Height12 Millimeter
Length32 Millimeter
Width11 Millimeter
Height12 Millimeter
Length32 Millimeter
Width11 Millimeter
Height12 Millimeter
Length32 Millimeter
Width11 Millimeter
Height12 Millimeter
Length32 Millimeter
Width11 Millimeter
Height12 Millimeter
Length32 Millimeter
Width11 Millimeter
Height12 Millimeter
Length32 Millimeter
Width11 Millimeter
Height12 Millimeter
Length32 Millimeter
Width11 Millimeter
Height12 Millimeter
Length32 Millimeter
Width11 Millimeter
Height12 Millimeter
Length32 Millimeter
Width11 Millimeter
Height12 Millimeter
Length32 Millimeter
Width11 Millimeter
Height12 Millimeter
Length32 Millimeter
Width11 Millimeter
Height12 Millimeter
Length32 Millimeter
Width11 Millimeter
Height12 Millimeter
Length32 Millimeter
Width11 Millimeter
Height12 Millimeter
Length32 Millimeter
Width11 Millimeter
Height12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100817493021340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00817493021340]

Moist Heat or Steam Sterilization

[00817493021340]

Moist Heat or Steam Sterilization

[00817493021340]

Moist Heat or Steam Sterilization

[00817493021340]

Moist Heat or Steam Sterilization

[00817493021340]

Moist Heat or Steam Sterilization

[00817493021340]

Moist Heat or Steam Sterilization

[00817493021340]

Moist Heat or Steam Sterilization

[00817493021340]

Moist Heat or Steam Sterilization

[00817493021340]

Moist Heat or Steam Sterilization

[00817493021340]

Moist Heat or Steam Sterilization

[00817493021340]

Moist Heat or Steam Sterilization

[00817493021340]

Moist Heat or Steam Sterilization

[00817493021340]

Moist Heat or Steam Sterilization

[00817493021340]

Moist Heat or Steam Sterilization

[00817493021340]

Moist Heat or Steam Sterilization

[00817493021340]

Moist Heat or Steam Sterilization

[00817493021340]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-10
Device Publish Date2019-06-01

On-Brand Devices [Hive-T IBFD]

00817493021456TLIF Hive-T Interbody Spacer, 9W, 26L, 13H, 18°
00817493021432TLIF Hive-T Interbody Spacer, 9W, 26L, 11H, 18°
00817493021401TLIF Hive-T Interbody Spacer, 9W, 26L, 13H, 13°
00817493021388TLIF Hive-T Interbody Spacer, 9W, 26L, 11H, 13°
00817493021289TLIF Hive-T Curved Interbody Spacer, 11W, 32L, 15H, 8°
00817493021272TLIF Hive-T Curved Interbody Spacer, 11W, 32L, 14H, 8°
00817493021265TLIF Hive-T Curved Interbody Spacer, 11W, 32L, 13H, 8°
00817493021258TLIF Hive-T Curved Interbody Spacer, 11W, 32L, 12H, 8°
00817493021241TLIF Hive-T Curved Interbody Spacer, 11W, 32L, 11H, 8°
00817493021234TLIF Hive-T Curved Interbody Spacer, 11W, 32L, 10H, 8°
00817493021227TLIF Hive-T Curved Interbody Spacer, 11W, 32L, 9H, 8°
00817493021210TLIF Hive-T Curved Interbody Spacer, 11W, 32L, 8H, 8°
00817493021203TLIF Hive-T Curved Interbody Spacer, 11W, 32L, 7H, 8°
0081749302137111W x 32L x 15H Curved TLIF Trial Assembly
0081749302136411W x 32L x 14H Curved TLIF Trial Assembly
0081749302135711W x 32L x 13H Curved TLIF Trial Assembly
0081749302134011W x 32L x 12H Curved TLIF Trial Assembly
0081749302133311W x 32L x 11H Curved TLIF Trial Assembly
0081749302132611W x 32L x 10H Curved TLIF Trial Assembly
0081749302131911W x 32L x 9H Curved TLIF Trial Assembly
0081749302130211W x 32L x 8H Curved TLIF Trial Assembly
0081749302129611W x 32L x 7H Curved TLIF Trial Assembly
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