FDA.reportPublic FDA data

Zodiac

Primary DI
00844856005648
Brand
Zodiac
Company
ALPHATEC SPINE, INC.
Model
62775-30
Device description
TI 7.5MM CANNULATED HIGH TOP POLYAXIAL SCREW ASM, 30MM LONG
Published
2015-10-07
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
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
MNHOrthosis, spondylolisthesis spinal fixation
MNIORTHOSIS, SPINAL PEDICLE FIXATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100685000
K123623000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100685000ZODIAC POLYAXIAL SPINAL FIXATION SYSTEMAlphatec Spine, Inc.2010-06-18KWP
K123623000ILLICO MIS POSTERIOR FIXATION SYSTEMAlphatec Spine, Inc.2013-02-14NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00844856005648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844856005648008448560056488448560056480844856005648

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation systemAn assembly of 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. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Millimeter
Outer Diameter7.5Millimeter

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
B678520297S0PressON™NEXUS SPINE, L.L.C.MNI2026-07-10
B678520297S0PressON™NEXUS SPINE, L.L.C.MNH2026-07-10
B678520298S0PressON™NEXUS SPINE, L.L.C.MNH2026-07-10
B678520298S0PressON™NEXUS SPINE, L.L.C.MNI2026-07-10
B678520299S0PressONNEXUS SPINE, L.L.C.MNH2026-07-10
B678520299S0PressONNEXUS SPINE, L.L.C.MNI2026-07-10
B678520300S0PressON™NEXUS SPINE, L.L.C.MNH2026-07-10
B678520300S0PressON™NEXUS SPINE, L.L.C.MNI2026-07-10
B678520301S0PressONNEXUS SPINE, L.L.C.MNH2026-07-10
B678520301S0PressONNEXUS SPINE, L.L.C.MNI2026-07-10
B678520302S0PressON™NEXUS SPINE, L.L.C.MNH2026-07-10
B678520302S0PressON™NEXUS SPINE, L.L.C.MNI2026-07-10
B678520303S0PressONNEXUS SPINE, L.L.C.MNH2026-07-10
B678520303S0PressONNEXUS SPINE, L.L.C.MNI2026-07-10
B678520304S0PressON™NEXUS SPINE, L.L.C.MNI2026-07-10
B678520304S0PressON™NEXUS SPINE, L.L.C.MNH2026-07-10
B678520305S0PressONNEXUS SPINE, L.L.C.MNH2026-07-10
B678520305S0PressONNEXUS SPINE, L.L.C.MNI2026-07-10
B678520306S0PressON™NEXUS SPINE, L.L.C.MNH2026-07-10
B678520306S0PressON™NEXUS SPINE, L.L.C.MNI2026-07-10
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-06-28
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-06-28
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-06-28
00643169101296MSB VERTEX® Reconstruction SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-06-27
10889981441555VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441609VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441616VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441623VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441661VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981005115NewportSeaspine Orthopedics CorporationMNH2015-09-24