Silex Sacroiliac Joint Fusion System

GUDID M697X0791240PC1

SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, PLASMA COATED, 12.5mm DIA X 40mm

Xtant Medical Holdings, Inc.

Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated
Primary Device IDM697X0791240PC1
NIH Device Record Keyc5288958-c1b7-4d6c-8d46-577d15b38d5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilex Sacroiliac Joint Fusion System
Version Model NumberX079-1240PC
Company DUNS081224143
Company NameXtant Medical Holdings, Inc.
Device Count1
DM Exempttrue
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com

Device Dimensions

Outer Diameter12.5 Millimeter
Length40 Millimeter
Outer Diameter12.5 Millimeter
Length40 Millimeter
Outer Diameter12.5 Millimeter
Length40 Millimeter
Outer Diameter12.5 Millimeter
Length40 Millimeter
Outer Diameter12.5 Millimeter
Length40 Millimeter
Outer Diameter12.5 Millimeter
Length40 Millimeter
Outer Diameter12.5 Millimeter
Length40 Millimeter
Outer Diameter12.5 Millimeter
Length40 Millimeter
Outer Diameter12.5 Millimeter
Length40 Millimeter
Outer Diameter12.5 Millimeter
Length40 Millimeter
Outer Diameter12.5 Millimeter
Length40 Millimeter
Outer Diameter12.5 Millimeter
Length40 Millimeter
Outer Diameter12.5 Millimeter
Length40 Millimeter
Outer Diameter12.5 Millimeter
Length40 Millimeter
Outer Diameter12.5 Millimeter
Length40 Millimeter
Outer Diameter12.5 Millimeter
Length40 Millimeter
Outer Diameter12.5 Millimeter
Length40 Millimeter
Outer Diameter12.5 Millimeter
Length40 Millimeter
Outer Diameter12.5 Millimeter
Length40 Millimeter
Outer Diameter12.5 Millimeter
Length40 Millimeter
Outer Diameter12.5 Millimeter
Length40 Millimeter
Outer Diameter12.5 Millimeter
Length40 Millimeter
Outer Diameter12.5 Millimeter
Length40 Millimeter
Outer Diameter12.5 Millimeter
Length40 Millimeter
Outer Diameter12.5 Millimeter
Length40 Millimeter
Outer Diameter12.5 Millimeter
Length40 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM697X0791240PC1 [Primary]

FDA Product Code

OURSacroiliac joint fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M697X0791240PC1]

Moist Heat or Steam Sterilization

[M697X0791240PC1]

Moist Heat or Steam Sterilization

[M697X0791240PC1]

Moist Heat or Steam Sterilization

[M697X0791240PC1]

Moist Heat or Steam Sterilization

[M697X0791240PC1]

Moist Heat or Steam Sterilization

[M697X0791240PC1]

Moist Heat or Steam Sterilization

[M697X0791240PC1]

Moist Heat or Steam Sterilization

[M697X0791240PC1]

Moist Heat or Steam Sterilization

[M697X0791240PC1]

Moist Heat or Steam Sterilization

[M697X0791240PC1]

Moist Heat or Steam Sterilization

[M697X0791240PC1]

Moist Heat or Steam Sterilization

[M697X0791240PC1]

Moist Heat or Steam Sterilization

[M697X0791240PC1]

Moist Heat or Steam Sterilization

[M697X0791240PC1]

Moist Heat or Steam Sterilization

[M697X0791240PC1]

Moist Heat or Steam Sterilization

[M697X0791240PC1]

Moist Heat or Steam Sterilization

[M697X0791240PC1]

Moist Heat or Steam Sterilization

[M697X0791240PC1]

Moist Heat or Steam Sterilization

[M697X0791240PC1]

Moist Heat or Steam Sterilization

[M697X0791240PC1]

Moist Heat or Steam Sterilization

[M697X0791240PC1]

Moist Heat or Steam Sterilization

[M697X0791240PC1]

Moist Heat or Steam Sterilization

[M697X0791240PC1]

Moist Heat or Steam Sterilization

[M697X0791240PC1]

Moist Heat or Steam Sterilization

[M697X0791240PC1]

Moist Heat or Steam Sterilization

[M697X0791240PC1]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-06-03
Device Publish Date2015-08-31

On-Brand Devices [Silex Sacroiliac Joint Fusion System]

M697X0791270PCDT1SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, PLASMA COATED, 12.5mm DIA X 70mm
M697X0791270PC1SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, PLASMA COATED, 12.5mm DIA X 70mm
M697X0791270DT1SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, 12.5mm DIA X 70mm
M697X07912701SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, 12.5mm DIA X 70mm
M697X0791265PCDT1SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, PLASMA COATED, 12.5mm DIA X 65mm
M697X0791265PC1SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, PLASMA COATED, 12.5mm DIA X 65mm
M697X0791265DT1SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, 12.5mm DIA X 65mm
M697X07912651SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, 12.5mm DIA X 65mm
M697X0791260PCDT1SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, PLASMA COATED, 12.5mm DIA X 60mm
M697X0791260PC1SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, PLASMA COATED, 12.5mm DIA X 60mm
M697X0791260DT1SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, 12.5mm DIA X 60mm
M697X07912601SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, 12.5mm DIA X 60mm
M697X0791255PCDT1SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, PLASMA COATED, 12.5mm DIA X 55mm
M697X0791255PC1SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, PLASMA COATED, 12.5mm DIA X 55mm
M697X0791255DT1SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, 12.5mm DIA X 55mm
M697X07912551SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, 12.5mm DIA X 55mm
M697X0791250PCDT1SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, PLASMA COATED, 12.5mm DIA X 50mm
M697X0791250PC1SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, PLASMA COATED, 12.5mm DIA X 50mm
M697X0791250DT1SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, 12.5mm DIA X 50mm
M697X07912501SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, 12.5mm DIA X 50mm
M697X0791245PCDT1SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, PLASMA COATED, 12.5mm DIA X 45mm
M697X0791245PC1SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, PLASMA COATED, 12.5mm DIA X 45mm
M697X0791245DT1SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, 12.5mm DIA X 45mm
M697X07912451SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, 12.5mm DIA X 45mm
M697X0791240PCDT1SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, PLASMA COATED, 12.5mm DIA X 40mm
M697X0791240PC1SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, PLASMA COATED, 12.5mm DIA X 40mm
M697X0791240DT1SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, 12.5mm DIA X 40mm
M697X07912401SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, 12.5mm DIA X 40mm
M697X0791235PCDT1SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, PLASMA COATED, 12.5mm DIA X 35mm
M697X0791235PC1SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, PLASMA COATED, 12.5mm DIA X 35mm
M697X0791235DT1SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, 12.5mm DIA X 35mm
M697X07912351SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, 12.5mm DIA X 35mm
M697X0791230PCDT1SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, PLASMA COATED, 12.5mm DIA X 30mm
M697X0791230PC1SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, PLASMA COATED, 12.5mm DIA X 30mm
M697X0791230DT1SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, 12.5mm DIA X 30mm
M697X07912301SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, 12.5mm DIA X 30mm
M697X07908021WASHER, SILEX, 15mm
M697X07908011WASHER, SILEX, 13mm
M697X07908001WASHER, SILEX, 11mm
M697X0790770DT1SILEX SACROILIAC LOCKING IMPLANT, DUAL THREAD, 7mm DIA X 70mm
M697X07907701SILEX SACROILIAC LOCKING IMPLANT, SINGLE THREAD, 7mm DIA X 70mm
M697X0790765DT1SILEX SACROILIAC LOCKING IMPLANT, DUAL THREAD, 7mm DIA X 65mm
M697X07907651SILEX SACROILIAC LOCKING IMPLANT, SINGLE THREAD, 7mm DIA X 65mm
M697X0790760DT1SILEX SACROILIAC LOCKING IMPLANT, DUAL THREAD, 7mm DIA X 60mm
M697X07907601SILEX SACROILIAC LOCKING IMPLANT, SINGLE THREAD, 7mm DIA X 60mm
M697X0790755DT1SILEX SACROILIAC LOCKING IMPLANT, DUAL THREAD, 7mm DIA X 55mm
M697X07907551SILEX SACROILIAC LOCKING IMPLANT, SINGLE THREAD, 7mm DIA X 55mm
M697X0790750DT1SILEX SACROILIAC LOCKING IMPLANT, DUAL THREAD, 7mm DIA X 50mm
M697X07907501SILEX SACROILIAC LOCKING IMPLANT, SINGLE THREAD, 7mm DIA X 50mm
M697X0790745DT1SILEX SACROILIAC LOCKING IMPLANT, DUAL THREAD, 7mm DIA X 45mm
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