FDA.reportPublic FDA data

Simpact

Primary DI
00190837119096
Brand
Simpact
Company
Life Spine, Inc.
Model
152-14-970
Published
2021-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201538000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201538000Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.2020-09-18OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190837119096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190837119096001908371190961908371190960190837119096

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
183641617
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190837085728ProLift Lateral149-4002149-40022019-11-19
00190837030919Pro Lift Instruments114-204-2114-204-22019-11-07
00190837030926Pro Lift Instruments114-204-3114-204-32019-11-07
00190837030957Pro Lift Instruments151-219151-2192019-11-07
00190837030964Pro Lift Instruments112-222112-2222019-11-07
00190837030988Pro Lift Instruments112-351112-3512019-11-07
00190837030995Pro Lift Instruments129-1006129-10062019-11-07
00190837031008Pro Lift Instruments129-1007129-10072019-11-07
00190837031015Pro Lift Instruments129-1008129-10082019-11-07
00190837031022Pro Lift Instruments129-1009129-10092019-11-07
00190837031039Pro Lift Instruments129-1010129-10102019-11-07
00190837031046Pro Lift Instruments129-1011129-10112019-11-07
00190837031053Pro Lift Instruments129-1012129-10122019-11-07
00190837031060Pro Lift Instruments129-1013129-10132019-11-07
00190837031077Pro Lift Instruments151-262151-2622019-11-07
00190837031084Pro Lift Instruments151-265151-2652019-11-07
00190837031091Pro Lift Instruments151-268151-2682019-11-07
00190837031107Pro Lift Instruments151-271151-2712019-11-07
00190837031121Pro Lift Instruments151-277151-2772019-11-07
00190837031138Pro Lift Instruments151-280151-2802019-11-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810112599275TriLEAPSynthes GmbHHWC2025-03-20
00810112599169TriLEAPSynthes GmbHHWC2025-03-18
00810112599176TriLEAPSynthes GmbHHWC2025-03-17
00810112599183TriLEAPSynthes GmbHHWC2025-03-17
00810112599190TriLEAPSynthes GmbHHWC2025-03-17
00810112599206TriLEAPSynthes GmbHHWC2025-03-17
00810112599213TriLEAPSynthes GmbHHWC2025-03-17
00810112599220TriLEAPSynthes GmbHHWC2025-03-17
00810112599237TriLEAPSynthes GmbHHWC2025-03-17
00810112599244TriLEAPSynthes GmbHHWC2025-03-17
00810112599251TriLEAPSynthes GmbHHWC2025-03-17
00810112599268TriLEAPSynthes GmbHHWC2025-03-17
00810112592245TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592252TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592429TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592450TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592467TriLeap Lower Etremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592474TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592634TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592832TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592849TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592986TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112592993TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593006TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593013TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593020TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593037TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593044TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593051TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593068TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22