SImmetry Implant, 14.5mm x 80mm

Primary DI
04260636675300
Brand
SImmetry Implant, 14.5mm x 80mm
Company
Paradigm Spine GmbH
Model
10-P14580-01
Published
2021-01-25
Public version status
Update
Distribution status
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
K151818000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151818000SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.2015-08-05OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260636675300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260636675300042606366753004260636675300

GMDN Terms#

Term, Definition table
TermDefinition
Sacroiliac joint transarticular fixation/arthrodesis implant, coatedA sterile implantable device designed to be inserted across the sacroiliac joint to provide temporary stabilization and to encourage long-term joint fusion, typically intended to alleviate pain from the joint. It is made of metal [e.g., titanium (Ti)] with a porous plasma spray coating, typically in the form of a cylinder or rod, possibly with a triangular cross-section. It is typically surgically implanted under fluoroscopic guidance and may include dedicated implantation instruments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
537619731
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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