FDA.reportPublic FDA data

Invictus

Primary DI
00190376475219
Brand
Invictus
Company
ALPHATEC SPINE, INC.
Model
17951-N
Device description
MIS Reduction T27 Polyaxial Screwdriver, Locking, Navigation
Published
2023-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153603000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153603000Alphatec Navigation InstrumentsAlphatec Spine, Inc.2016-04-29OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190376475219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376475219001903764752191903764752190190376475219

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. 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
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

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Primary DI, Brand, Company table
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00840493422534RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422541RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422558RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422565RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422572RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422589RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422268RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422275RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422282RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422299RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422305RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422312RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422329RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422336RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422343RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422350RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02