FDA.reportPublic FDA data

Invictus OsseoScrew

Primary DI
00190376349268
Brand
Invictus OsseoScrew
Company
ALPHATEC SPINE, INC.
Model
17904
Device description
Osseoscrew, Collapse Handle
Published
2021-12-15
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
NKBThoracolumbosacral pedicle screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202327000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202327000Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.2020-10-15NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190376349268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376349268001903763492681903763492680190376349268

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. 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
00190376649474CONTOUR3DAIX761032026-09-25
00190376652313CONTOUR3DAIX761012026-09-25
00190376652320CONTOUR3DAIX761022026-09-25
00190376652337CONTOUR3DAIX761042026-09-25
00190376668307CONTOUR3DAIX760002026-09-25
00190376733470CONTOUR3DC3DRODA2026-09-25
00190376778372InvictusVMRIN2026-08-19
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888857598164Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598171Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598188Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598232Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598249Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
00613994887955TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-09-17
00885074494722TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
00613994888143TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
04546540147257XIA IIStryker CorporationNKB2014-12-08
04546540147769XIA IIStryker CorporationNKB2014-12-08
04546540147806XIA IIStryker CorporationNKB2014-12-08
04546540147905XIA IIStryker CorporationNKB2014-12-08
04546540147912XIA IStryker CorporationNKB2014-12-08
04546540147929XIA IStryker CorporationNKB2014-12-08
04546540147936XIA IStryker CorporationNKB2014-12-08
04546540147974XIA IStryker CorporationNKB2014-12-08
04546540147981XIA IStryker CorporationNKB2014-12-08
04546540147998XIA IStryker CorporationNKB2014-12-08
04546540148001XIA IIStryker CorporationNKB2014-12-08
04546540148018XIA IIStryker CorporationNKB2014-12-08
04546540148025XIA IIStryker CorporationNKB2014-12-08
04546540148735XIA IIStryker CorporationNKB2014-12-08
04546540148742XIA IIStryker CorporationNKB2014-12-08
04546540148759XIA IIStryker CorporationNKB2014-12-08