FDA.reportPublic FDA data

Invictus

Primary DI
00190376778372
Brand
Invictus
Company
ALPHATEC SPINE, INC.
Model
VMRIN
Device description
Invictus MIS Reduction Instruments
Published
2026-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190376778372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376778372001903767783721903767783720190376778372

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(760)431-9286Regulatory@alphatecspine.com

Regulatory Flags#

DUNS number
602465783
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190376778396InvictusVMTIN2026-08-19
00190376768847Invictus171442026-08-17
00190376544397Invictus17920-012026-07-30
00190376544403Invictus17920-022026-07-30
00190376544410Invictus17920-032026-07-30
00190376544427Invictus17920-042026-07-30
00190376544434Invictus17920-052026-07-30
00190376544441Invictus17920-062026-07-30
00190376544458Invictus17920-072026-07-30
00190376544465Invictus17920-082026-07-30
00190376544472Invictus17920-092026-07-30
00190376544489Invictus17920-102026-07-30
00190376544496Invictus179212026-07-30
00190376544502Invictus179222026-07-30
00190376544519Invictus179242026-07-30
00190376544861Invictus17920-112026-07-30
00190376544878Invictus17920-122026-07-30
00190376766133InvictusVMDCORT2026-07-30
00190376732008Segmental Plating System338-0214-S2026-07-27
00190376732015Segmental Plating System338-0215-S2026-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376778396InvictusALPHATEC SPINE, INC.FSM2026-08-19
08800322759516Torque Limiting HandleGS Medical Co., Ltd.FSM2026-08-18
10806378116810ACUMEDAcumed LLCFSM2026-08-18
10806378116827ACUMEDAcumed LLCFSM2026-08-18
10806378116841ACUMEDAcumed LLCFSM2026-08-18
10806378116858ACUMEDAcumed LLCFSM2026-08-18
G8791062750DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879107193L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879107193S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879107241L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879107241M0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879107241S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G8791072770DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G8791072780DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G8791072790DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G8791072800DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879107280S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC050DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC05S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC07S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC100DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC10F0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC10S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC150DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC200DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC20A0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC20F0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC21N0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
03700879517803airlock®NOVASTEPFSM2026-08-17
04099797012774SCREW-LINE Surgery trayALTATEC GmbHFSM2026-08-17