APEX Spine System

GUDID M824SCP601121

2mm Open Washer for Large Polyaxial Pedicle Screws

SPINECRAFT, LLC

Implantable bone washer
Primary Device IDM824SCP601121
NIH Device Record Key89bb6430-7297-4a03-86c8-34833a34165e
Commercial Distribution Discontinuation2024-09-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAPEX Spine System
Version Model NumberSC-P60-112
Company DUNS783908713
Company NameSPINECRAFT, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM824SCP601121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBOrthosis, spinal pedicle fixation, for degenerative disc disease

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M824SCP601121]

Moist Heat or Steam Sterilization

[M824SCP601121]

Moist Heat or Steam Sterilization

[M824SCP601121]

Moist Heat or Steam Sterilization

[M824SCP601121]

Moist Heat or Steam Sterilization

[M824SCP601121]

Moist Heat or Steam Sterilization

[M824SCP601121]

Moist Heat or Steam Sterilization

[M824SCP601121]

Moist Heat or Steam Sterilization

[M824SCP601121]

Moist Heat or Steam Sterilization

[M824SCP601121]

Moist Heat or Steam Sterilization

[M824SCP601121]

Moist Heat or Steam Sterilization

[M824SCP601121]

Moist Heat or Steam Sterilization

[M824SCP601121]

Moist Heat or Steam Sterilization

[M824SCP601121]

Moist Heat or Steam Sterilization

[M824SCP601121]

Moist Heat or Steam Sterilization

[M824SCP601121]

Moist Heat or Steam Sterilization

[M824SCP601121]

Moist Heat or Steam Sterilization

[M824SCP601121]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-09-05
Device Publish Date2014-09-24

On-Brand Devices [APEX Spine System]

00193082031021APEX C-Block
00193082031014APEX Demi Open-Closed Side-by-Side Rod Connector Dia.5.50 to Dia.5.50
00193082031007APEX Open-Closed Side-by-Side Rod Connector Dia.5.50 to Dia.5.50
00193082030994APEX Demi Open-Closed Side-by-Side Rod Connector Dia.6 to Dia.5.50
00193082030987APEX Open-Closed Side-by-Side Rod Connector Dia.6 to Dia.5.50
00193082030970APEX Demi Open-Closed Side-by-Side Rod Connector Dia.6 to Dia.6
00193082030963APEX Open-Closed Side-by-Side Rod Connector Dia.6 to Dia.6
00193082030956APEX Tandem Rod Connector Dia.5.50 to Dia.5.50mm- Growing Rod, 80mm
00193082030949APEX Tandem Rod Connector Dia.5.50 to Dia.5.50mm- Growing Rod, 70mm
00193082030932APEX Tandem Rod Connector Dia.5.50 to Dia.5.50mm- Growing Rod, 60mm
00193082030925APEX Tandem Rod Connector Dia.5.50 to Dia.5.50mm- Growing Rod, 50mm
00193082030918APEX Tandem Rod Connector Dia.5.50 to Dia.5.50mm- Growing Rod, 40mm
00193082030901APEX Tandem Rod Connector Dia.5.50mm
00193082030895APEX Demi Side-by-Side Rod Connector Dia.5.50mm
00193082030888APEX Side-by-Side Rod Connector Dia.5.50mm
00193082030871APEX Tandem Rod Connector Dia.6.00 to Dia.6.00mm- Growing Rod, 80mm
00193082030864APEX Tandem Rod Connector Dia.6.00 to Dia.6.00mm- Growing Rod, 70mm
00193082030857APEX Tandem Rod Connector Dia.6.00 to Dia.6.00mm- Growing Rod, 60mm
00193082030840APEX Tandem Rod Connector Dia.6.00 to Dia.6.00mm- Growing Rod, 50mm
00193082030833APEX Tandem Rod Connector Dia.6.00 to Dia.6.00mm- Growing Rod, 40mm
00193082030826APEX Tandem Rod Connector Dia.5.50 to Dia.6.00mm- Growing Rod, 80mm
00193082030819APEX Tandem Rod Connector Dia.5.50 to Dia.6.00mm- Growing Rod, 70mm
00193082030802APEX Tandem Rod Connector Dia.5.50 to Dia.6.00mm- Growing Rod, 60mm
00193082030796APEX Tandem Rod Connector Dia.5.50 to Dia.6.00mm- Growing Rod, 50mm
00193082030789APEX Tandem Rod Connector Dia.5.50 to Dia.6.00mm- Growing Rod, 40mm
00193082030772APEX Tandem Rod Connector Dia.5.50 to Dia.6mm
00193082030765APEX Demi Side-by-Side Rod Connector Dia.5.50 to Dia.6mm
00193082030758APEX Side-by-Side Rod Connector Dia.5.50 to Dia.6mm
00193082030741APEX Tandem Rod Connector Dia.6mm
00193082030734APEX Demi Side-by Side Rod Connector Dia.6mm
00193082030727APEX Side-by-Side Rod Connector Dia.6mm
00193082030710APEX M6 Set Screw for Lateral Slotted Connectors
00193082030703APEX XL T30 Set Screw
00193082030697APEX T-30 Set Screws 11.0mm OD for Large Poly Screws
00193082030680APEX T-30 Set Screw, 9.5mm OD for Mono, Poly Screws and Hooks
00193082030673APEX T-20 Set Screw, 6mm OD for Cross Connectors
00193082030666APEX M6 Set Screw for Lateral Closed, Rod and Tandem Connectors
00193082030659APEX Ti Offset Right Hook 9.5mm
00193082030642APEX Ti Offset Right Hook 8.0mm
00193082030635APEX Ti Offset Right Hook 6.5mm
00193082030628APEX Ti Offset Right Hook 5.0mm
00193082030611APEX Ti Offset Left Hook 9.5mm
00193082030604APEX Ti Offset Left Hook 8.0mm
00193082030598APEX Ti Offset Left Hook 6.5mm
00193082030581APEX Ti Offset Left Hook 5.0mm
00193082030574APEX Ti Wide Laminar Hook 9.5mm
00193082030567APEX Ti Wide Laminar Hook 8.0mm
00193082030550APEX Ti Wide Laminar Hook 6.5mm
00193082030543APEX Ti Wide Laminar Hook 5.0mm
00193082030536APEX Ti Bifid Hook 9.5mm

Trademark Results [APEX Spine System]

Mark Image

Registration | Serial
Company
Trademark
Application Date
APEX SPINE SYSTEM
APEX SPINE SYSTEM
85820194 not registered Dead/Abandoned
SpineCraft, LLC
2013-01-10
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