FDA.reportPublic FDA data

Invictus

Primary DI
00190376249605
Brand
Invictus
Company
ALPHATEC SPINE, INC.
Model
18000-35-26
Device description
Polyaxial Screw, 3.5mm X 26mm
Published
2020-08-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKGPosterior cervical screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200936000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200936000Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.2020-05-22NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190376249605PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376249605001903762496051903762496050190376249605

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length26Millimeter
Outer Diameter3.5Millimeter

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
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190376541471ATEC Lateral Navigation Disc Prep Instruments267-01-000-10-N2024-12-18
00190376529158ATEC Posterior Navigation Disc Prep Instruments244-01-000-06-N2024-04-20
00190376529189ATEC Posterior Navigation Disc Prep Instruments244-01-000-12-N2024-04-20
00190376476162ATEC Lateral Navigation Disc Prep Instruments266-01-000-08-N2023-08-26
00190376476179ATEC Lateral Navigation Disc Prep Instruments266-01-000-10-N2023-08-26
00190376476186ATEC Lateral Navigation Disc Prep Instruments266-01-000-12-N2023-08-26
00190376522906ATEC Lateral Navigation Disc Prep Instruments266-01-000-14-N2023-08-26
00840180512395General InstrumentsCI-11129-34242026-05-15
00840180543214General InstrumentsCI-118992026-05-15
00840180543542General InstrumentsCI-11915-302026-05-15
00840180544785General InstrumentsCI-11939-080-R2026-05-15
00840180544914General InstrumentsCI-11939-080-L2026-05-15
00840180545324General InstrumentsCI-11968-06-S2026-05-15
00840180545331General InstrumentsCI-11968-06-L2026-05-15
00840180545362General InstrumentsCI-11968-S2026-05-15
00840180545416General InstrumentsCI-11972-012026-05-15
00840180545423General InstrumentsCI-11972-032026-05-15
00840180545430General InstrumentsCI-11972-022026-05-15
00840180545447General InstrumentsCI-11972-042026-05-15
00840180545461General InstrumentsCI-11969-L2026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536085491neon3Ulrich GmbH & Co. KGNKG2026-05-28
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07630345705877M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705884M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705891M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705907M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705914M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705921M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705938M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705945M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705952M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630971299559M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-30
07630971299566M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-30
07630971299573M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-30
07630971299580M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-30
07630971299597M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-30
07630971299528M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-25
07630971299535M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-25
07630971299542M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-25
07630971299368M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299375M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299382M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299399M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299405M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299412M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299429M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299436M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299443M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299450M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299467M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19