FDA.reportPublic FDA data

Invictus

Primary DI
00190376544502
Brand
Invictus
Company
ALPHATEC SPINE, INC.
Model
17922
Device description
MIS Decortication Reamer
Published
2026-07-30
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
HTOREAMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190376544502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376544502001903765445021903765445020190376544502

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, reusableAn orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. 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
false
Combination product
false
Lot or batch
true
Serial number
false
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
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
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
00190376732022Segmental Plating System338-0216-S2026-07-27
00190376732039Segmental Plating System338-0217-S2026-07-27
00190376732046Segmental Plating System338-0218-S2026-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701089526364AMPLITUDEAMPLITUDE SASHTO2026-07-29
03701089526371AMPLITUDEAMPLITUDE SASHTO2026-07-29
03701089526388AMPLITUDEAMPLITUDE SASHTO2026-07-29
03700569676636Newclip InstrumentsNEWCLIP TECHNICSHTO2026-07-28
03700569676643Newclip InstrumentsNEWCLIP TECHNICSHTO2026-07-28
03700569676650Newclip InstrumentsNEWCLIP TECHNICSHTO2026-07-28
18059015378320Flexible Reamers SystemORTHOFIX SRLHTO2026-07-23
18059015378337Flexible Reamers SystemORTHOFIX SRLHTO2026-07-23
18059015378344Flexible Reamers SystemORTHOFIX SRLHTO2026-07-23
18059015378351Flexible Reamers SystemORTHOFIX SRLHTO2026-07-23
18059015378399Flexible Reamers SystemORTHOFIX SRLHTO2026-07-23
10810128461426Back Drill 4.5 X 7.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-07-22
10810128461440Back Drill 4.5 X 8.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-07-22
10810128461457Back Drill 4.5 X 8.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-07-22
10810128461464Back Drill 4.5 X 9.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-07-22
10810128461471Back Drill 4.5 x 9.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-07-22
10810128461488Back Drill 4.5 X 10.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-07-22
10810128463338Back Drill 6.0 X 11.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-07-22
00889024710580Custom Femoral Lateralizing ReamerZimmer, Inc.HTO2026-07-20
B504OMAR14510ArthrexProvisionHTO2026-07-20
B356JB405140American MedicalsAmerican MedicalsHTO2026-07-06
00889024701502Identity® Shoulder SystemZimmer, Inc.HTO2026-06-10
00889024701519Identity® Shoulder SystemZimmer, Inc.HTO2026-06-10
00810094692797Tibial Reamer, Square Tip, Klassic ONE 25/50mmTOTAL JOINT ORTHOPEDICS, INC.HTO2026-06-09
00810030810575InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810582InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810599InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810605InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810612InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810629InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01