FDA.reportPublic FDA data

Simmetry

Primary DI
00810142530835
Brand
Simmetry
Company
Sivantage, Inc.
Model
B
Catalog number
10-PL125105-01
Device description
Simmetry Lag Implant 12.5 mm x 105 mm
Published
2025-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OURSacroiliac Joint Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OURSacroiliac Joint FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810142530835PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810142530835008101425308358101425308350810142530835

GMDN Terms#

Term, Definition table
TermDefinition
Sacroiliac joint intra-articular arthrodesis implantAn implantable device designed to achieve and maintain the distraction of degenerated articular surfaces of the sacroiliac joint to assist in intra- and extra-articular bone grafting and fusion (arthrodesis), typically performed to alleviate pain from the sacroiliac joints in skeletally mature patients. The device is a tapered tube made of titanium alloy which has radial fenestrations to encourage bony in-growth. It is surgically implanted under fluoroscopic guidance using an assortment of dedicated tools. It is available in several sizes and intended for permanent implantation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-855-622-9100customerservice@sivantage.net

Regulatory Flags#

DUNS number
119049891
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810142530149SimmetryB10-P12540-012025-03-10
00810142530156SimmetryB10-P12545-012025-03-10
00810142530163SimmetryB10-P12550-012025-03-10
00810142530170SimmetryB10-P12555-012025-03-10
00810142530187SimmetryB10-P12560-012025-03-10
00810142530194SimmetryB10-P12565-012025-03-10
00810142530200SimmetryB10-P12570-012025-03-10
00810142530217SimmetryB10-P12580-012025-03-10
00810142530224SimmetryB10-P12590-012025-03-10
00810142530231SimmetryB10-P125100-012025-03-10
00810142530248SimmetryB10-P14540-012025-03-10
00810142530255SimmetryB10-P14545-012025-03-10
00810142530262SimmetryB10-P14550-012025-03-10
00810142530279SimmetryB10-P14555-012025-03-10
00810142530286SimmetryB10-P14560-012025-03-10
00810142530422SimmetryB10-P14530-012025-03-10
00810142530439SimmetryB10-P14535-012025-03-10
00810142530446SimmetryB10-P14565-012025-03-10
00810142530453SimmetryB10-P14570-012025-03-10
00810142530460SimmetryB10-P14575-012025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327075830ASNISStryker GmbHOUR2015-11-11
07613327076189ASNISStryker GmbHOUR2015-11-11
07613327076301ASNISStryker GmbHOUR2015-11-11
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07613327076721ASNISStryker GmbHOUR2015-11-11
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07613327077049ASNISStryker GmbHOUR2015-11-11
07613327077308ASNISStryker GmbHOUR2015-11-11
07613327077315ASNISStryker GmbHOUR2015-11-11
07613327077346ASNISStryker GmbHOUR2015-11-11
07613327077391ASNISStryker GmbHOUR2015-11-11
07613327077414ASNISStryker GmbHOUR2015-11-11
07613327077483ASNISStryker GmbHOUR2015-11-11
07613327077513ASNISStryker GmbHOUR2015-11-11
07613327077544ASNISStryker GmbHOUR2015-11-11
07613327077582ASNISStryker GmbHOUR2015-11-11
07613327077605ASNISStryker GmbHOUR2015-11-11
07613327077612ASNISStryker GmbHOUR2015-11-11
07613327077643ASNISStryker GmbHOUR2015-11-11
07613327077674ASNISStryker GmbHOUR2015-11-11
07613327077704ASNISStryker GmbHOUR2015-11-11
07613327077735ASNISStryker GmbHOUR2015-11-11
07613154158980NAStryker GmbHOUR2015-09-24
07613252232674ASNISStryker GmbHOUR2015-09-24
07613252232681ASNISStryker GmbHOUR2015-09-24
07613252232698ASNISStryker GmbHOUR2015-09-24
07613252232704ASNISStryker GmbHOUR2015-09-24
07613252232711ASNISStryker GmbHOUR2015-09-24
07613252232728ASNISStryker GmbHOUR2015-09-24
07613252232735ASNISStryker GmbHOUR2015-09-24