FDA.reportPublic FDA data

SImmetry®

Primary DI
00817672011018
Brand
SImmetry®
Company
ZYGA TECHNOLOGY, INC.
Model
10-S10590-01
Catalog number
10-S10590-01
Device description
SIJ Implant 10.5mm X 90mm
Published
2015-10-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OURSacroiliac Joint Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OURSacroiliac Joint FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141549000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141549000SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.2015-01-15OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817672011018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817672011018008176720110188176720110180817672011018

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
024049072
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817672010066SImmetry®10-P12540-0110-P12540-012015-10-15
00817672010073SImmetry®10-P12550-0110-P12550-012015-10-15
00817672010080SImmetry®10-P12560-0110-P12560-012015-10-15
00817672010097SImmetry®10-P12570-0110-P12570-012015-10-15
00817672010356SImmetry®10-P12545-0110-P12545-012015-10-15
00817672010363SImmetry®10-P12555-0110-P12555-012015-10-15
00817672010394SImmetry®10-P12580-0110-P12580-012015-10-15
00817672010417SImmetry®10-P12590-0110-P12590-012015-10-15
00817672010486SImmetry®10-S08540-0110-S08540-012015-10-15
00817672010493SImmetry®10-S08545-0110-S08545-012015-10-15
00817672010509SImmetry®10-S08550-0110-S08550-012015-10-15
00817672010516SImmetry®10-S08555-0110-S08555-012015-10-15
00817672010523SImmetry®10-S08560-0110-S08560-012015-10-15
00817672010547SImmetry®10-S08570-0110-S08570-012015-10-15
00817672010561SImmetry®10-S08580-0110-S08580-012015-10-15
00817672010585SImmetry®10-S08590-0110-S08590-012015-10-15
00817672010806SImmetry®10-SL08570-0110-SL08570-012015-10-15
00817672010820SImmetry®10-SL08580-0110-SL08580-012015-10-15
00817672010844SImmetry®10-SL08590-0110-SL08590-012015-10-15
00817672010936SImmetry®10-S10550-0110-S10550-012015-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M719GL201TL0SIros-XGenesys Orthopedics Systems LLCOUR2026-07-23
00889929072745NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCOUR2026-07-17
18257200140084Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200140091Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143368Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143375Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143382Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143399Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143405Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143412Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143429Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143436Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143443Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143450Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146079Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146086Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146093Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146109Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146116Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146123Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146130Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146147Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146154Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146161Firebird SI FusionOrthofix US LLCOUR2026-07-17
M179GSI265STS0Sacroiliac Joint FusionGenesys Orthopedics Systems LLCOUR2026-07-14
M719G120140SIros-XGenesys Orthopedics Systems LLCOUR2026-07-14
M719GGSI265XLGS0Sacroiliac Joint FusionGenesys Orthopedics Systems LLCOUR2026-07-14
00889929072738NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCOUR2026-05-01
07613327075830ASNISStryker GmbHOUR2015-11-11
07613327076189ASNISStryker GmbHOUR2015-11-11