FDA.reportPublic FDA data

ATEC Lateral Navigation Disc Prep Instruments

Primary DI
00190376509785
Brand
ATEC Lateral Navigation Disc Prep Instruments
Company
ALPHATEC SPINE, INC.
Model
266-15-000-12-N
Device description
LIF NAV, SHAVER 12mm
Published
2023-08-26
Public version status
Update
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
K223765000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223765000ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.2023-03-23OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190376509785PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376509785001903765097851903765097850190376509785

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic chiselA hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width12Millimeter

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
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
00190376544502Invictus179222026-07-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606195546Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195553Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195560Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195577Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195584Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195591Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195607Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195614Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195621Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195638Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195645Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195652Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00885556925171REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925188REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925195REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925201REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925218REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925225REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925232REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925249REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
04054896090955VERTICALESilony Medical GmbHOLO2026-07-30
04054896090962VERTICALESilony Medical GmbHOLO2026-07-30
04054896090979VERTICALESilony Medical GmbHOLO2026-07-30
04054896090986VERTICALESilony Medical GmbHOLO2026-07-30
04054896090993VERTICALESilony Medical GmbHOLO2026-07-30
04054896091006VERTICALESilony Medical GmbHOLO2026-07-30
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04054896091037VERTICALESilony Medical GmbHOLO2026-07-30
04054896091044VERTICALESilony Medical GmbHOLO2026-07-30