FDA.reportPublic FDA data

AMP-LTX

Primary DI
00190376515236
Brand
AMP-LTX
Company
ALPHATEC SPINE, INC.
Model
612-50-65
Device description
Lateral Bone Screw, 5.0 x 65mm
Published
2023-04-27
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
OVDIntervertebral fusion device with integrated fixation, lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223611000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223611000Calibrate LTX Interbody SystemAlphatec Spine, Inc.2023-03-29MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190376515236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376515236001903765152361903765152360190376515236

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a stabilization device (e.g., rod, plate) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

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
00841523178865Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523178872Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523178889Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523178896Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523178902Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523178919Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523178926Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523178933Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523178940Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523178957Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523178964Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523178971Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523178988Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523178995Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523179008Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523179015Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523179022Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523179039Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523179046Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523179053Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523179060Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523179077Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00841523179084Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OVD2026-05-22
00810141040007Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCOVD2026-03-05
10889981304713MeridianSeaspine Orthopedics CorporationOVD2026-03-03
10889981304720MeridianSeaspine Orthopedics CorporationOVD2026-03-03
10889981326241REEF LSeaspine Orthopedics CorporationOVD2026-03-03
00840067210710TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210727TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210734TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20