Blue Topaz Sacroiliac Screw System 3000-09580

GUDID B062300009580

Sacroiliac Screw, 9.5x80mm, Blue Topaz

Osseus Fusion Systems, LLC

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated
Primary Device IDB062300009580
NIH Device Record Key98ea37fc-66e5-4d2f-bb30-30091fe27832
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlue Topaz Sacroiliac Screw System
Version Model Number3000-09580
Catalog Number3000-09580
Company DUNS933442068
Company NameOsseus Fusion Systems, 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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB062300009580 [Primary]

FDA Product Code

OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B062300009580]

Moist Heat or Steam Sterilization

[B062300009580]

Moist Heat or Steam Sterilization

[B062300009580]

Moist Heat or Steam Sterilization

[B062300009580]

Moist Heat or Steam Sterilization

[B062300009580]

Moist Heat or Steam Sterilization

[B062300009580]

Moist Heat or Steam Sterilization

[B062300009580]

Moist Heat or Steam Sterilization

[B062300009580]

Moist Heat or Steam Sterilization

[B062300009580]

Moist Heat or Steam Sterilization

[B062300009580]

Moist Heat or Steam Sterilization

[B062300009580]

Moist Heat or Steam Sterilization

[B062300009580]

Moist Heat or Steam Sterilization

[B062300009580]

Moist Heat or Steam Sterilization

[B062300009580]

Moist Heat or Steam Sterilization

[B062300009580]

Moist Heat or Steam Sterilization

[B062300009580]

Moist Heat or Steam Sterilization

[B062300009580]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-16
Device Publish Date2023-06-08

On-Brand Devices [Blue Topaz Sacroiliac Screw System]

B062300011570Sacroiliac Screw, 11.5x70mm, Blue Topaz
B062300011565Sacroiliac Screw, 11.5x65mm, Blue Topaz
B062300011560Sacroiliac Screw, 11.5x60mm, Blue Topaz
B062300011555Sacroiliac Screw, 11.5x55mm, Blue Topaz
B062300011550Sacroiliac Screw, 11.5x50mm, Blue Topaz
B062300011545Sacroiliac Screw, 11.5x45mm, Blue Topaz
B062300011540Sacroiliac Screw, 11.5x40mm, Blue Topaz
B062300011535Sacroiliac Screw, 11.5x35mm, Blue Topaz
B062300011530Sacroiliac Screw, 11.5x30mm, Blue Topaz
B062300010580Sacroiliac Screw, 10.5x80mm, Blue Topaz
B062300010575Sacroiliac Screw, 10.5x75mm, Blue Topaz
B062300010570Sacroiliac Screw, 10.5x70mm, Blue Topaz
B062300010565Sacroiliac Screw, 10.5x65mm, Blue Topaz
B062300010560Sacroiliac Screw, 10.5x60mm, Blue Topaz
B062300010555Sacroiliac Screw, 10.5x55mm, Blue Topaz
B062300010550Sacroiliac Screw, 10.5x50mm, Blue Topaz
B062300010545Sacroiliac Screw, 10.5x45mm, Blue Topaz
B062300010540Sacroiliac Screw, 10.5x40mm, Blue Topaz
B062300010535Sacroiliac Screw, 10.5x35mm, Blue Topaz
B062300010530Sacroiliac Screw, 10.5x30mm, Blue Topaz
B062300009580Sacroiliac Screw, 9.5x80mm, Blue Topaz
B062300009575Sacroiliac Screw, 9.5x75mm, Blue Topaz
B062300009570Sacroiliac Screw, 9.5x70mm, Blue Topaz
B062300009565Sacroiliac Screw, 9.5x65mm, Blue Topaz
B062300009560Sacroiliac Screw, 9.5x60mm, Blue Topaz
B062300009555Sacroiliac Screw, 9.5x55mm, Blue Topaz
B062300009550Sacroiliac Screw, 9.5x50mm, Blue Topaz
B062300009545Sacroiliac Screw, 9.5x45mm, Blue Topaz
B062300009540Sacroiliac Screw, 9.5x40mm, Blue Topaz
B062300009535Sacroiliac Screw, 9.5x35mm, Blue Topaz
B062300009530Sacroiliac Screw, 9.5x30mm, Blue Topaz
B062300008580Sacroiliac Screw, 8.5x80mm, Blue Topaz
B062300008575Sacroiliac Screw, 8.5x75mm, Blue Topaz
B062300008570Sacroiliac Screw, 8.5x70mm, Blue Topaz
B062300008565Sacroiliac Screw, 8.5x65mm, Blue Topaz
B062300008560Sacroiliac Screw, 8.5x60mm, Blue Topaz
B062300008555Sacroiliac Screw, 8.5x55mm, Blue Topaz
B062300008550Sacroiliac Screw, 8.5x50mm, Blue Topaz
B062300008545Sacroiliac Screw, 8.5x45mm, Blue Topaz
B062300008540Sacroiliac Screw, 8.5x40mm, Blue Topaz
B062300008535Sacroiliac Screw, 8.5x35mm, Blue Topaz
B062300008530Sacroiliac Screw, 8.5x30mm, Blue Topaz
B062300012580Sacroiliac Screw, 12.5x80mm, Blue Topaz
B062300012575Sacroiliac Screw, 12.5x75mm, Blue Topaz
B062300012570Sacroiliac Screw, 12.5x70mm, Blue Topaz
B062300012565Sacroiliac Screw, 12.5x65mm, Blue Topaz
B062300012560Sacroiliac Screw, 12.5x60mm, Blue Topaz
B062300012555Sacroiliac Screw, 12.5x55mm, Blue Topaz
B062300012550Sacroiliac Screw, 12.5x50mm, Blue Topaz
B062300012545Sacroiliac Screw, 12.5x45mm, Blue Topaz
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