Blustone Synergy Cervical Inserter

GUDID 00810482030651

The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899. The cervical implant inserter is designed to allow for disassembly during cleaning and sterilization.Instructions regarding disassembly of the inserter instrument are provided in the product insert.

BLUSTONE SYNERGY, LLC

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable
Primary Device ID00810482030651
NIH Device Record Keye0e79527-e2e6-4cff-a7b3-a9bdb2e4c2cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlustone Synergy Cervical Inserter
Version Model Number9000-CI01
Company DUNS033467608
Company NameBLUSTONE SYNERGY, 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

Phone8002329108
Emailadmin@blustonesynergy.com
Phone8002329108
Emailadmin@blustonesynergy.com

Device Dimensions

Length6.5 Inch
Length6.5 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100810482030651 [Primary]

FDA Product Code

FZXGuide, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810482030651]

Moist Heat or Steam Sterilization


[00810482030651]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-23
Device Publish Date2018-01-29

Devices Manufactured by BLUSTONE SYNERGY, LLC

00810482030019 - Blustone Synergy Cervical Interbody Fusion System (Slate)2020-02-24 The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel and 6° lordotic cages in two foot
00810482030026 - Blustone Synergy Cervical Interbody Fusion System (Slate)2020-02-24 The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel and 6° lordotic cages in two foot
00810482030033 - Blustone Synergy Cervical Interbody Fusion System (Slate)2020-02-24 The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel and 6° lordotic cages in two foot
00810482030040 - Blustone Synergy Cervical Interbody Fusion System (Slate)2020-02-24 The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel and 6° lordotic cages in two foot
00810482030057 - Blustone Synergy Cervical Interbody Fusion System (Slate)2020-02-24 The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel and 6° lordotic cages in two foot
00810482030064 - Blustone Synergy Cervical Interbody Fusion System (Slate)2020-02-24 The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel and 6° lordotic cages in two foot
00810482030071 - Blustone Synergy Cervical Interbody Fusion System (Slate)2020-02-24 The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel and 6° lordotic cages in two foot
00810482030088 - Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)2020-02-24 The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configurations of various heights. The impl

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