FDA.reportPublic FDA data

AMP-LTX

Primary DI
00190376533582
Brand
AMP-LTX
Company
ALPHATEC SPINE, INC.
Model
622-2-001
Device description
AMP-LTX Center Screw
Published
2023-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral fusion device with bone graft, lumbar
PHMIntervertebral fusion device with bone graft, thoracic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
PHMIntervertebral Fusion Device With Bone Graft, ThoracicOrthopedic2

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
00190376533582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376533582001903765335821903765335820190376533582

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 correction/stabilization device (e.g., rod, plate, tether) 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
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190376509747SafeOp 3AIX118142026-03-24
00840180539521General InstrumentsCI-11843-082025-10-17
00840180541173General InstrumentsCI-11872-1002025-10-17
00840180541180General InstrumentsCI-11872-2002025-10-17
00840180541197General InstrumentsCI-11872-3002025-10-17
00840180541203General InstrumentsCI-11872-4002025-10-17
00190376633428Valence Robotic Navigation System525-10202026-02-26
00190376633435Valence Robotic Navigation System525-10302026-02-26
00190376633442Valence Robotic Navigation System525-1050-0952026-02-26
00190376633459Valence Robotic Navigation System525-1050-1252026-02-26
00190376633466Valence Robotic Navigation System525-1050-1502026-02-26
00190376633473Valence Robotic Navigation System525-10702026-02-26
00190376633480Valence Robotic Navigation System525-10902026-02-26
00190376633497Valence Robotic Navigation System525-10912026-02-26
00190376633503Valence Robotic Navigation System525-11002026-02-26
00190376633510Valence Robotic Navigation System525-11012026-02-26
00190376633527Valence Robotic Navigation System525-11102026-02-26
00190376633534Valence Robotic Navigation System525-10402026-02-26
00190376634340Valence Robotic Navigation System525-10412026-02-26
00190376643670Valence Robotic Navigation System525-10602026-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841523178865Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178872Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178889Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178896Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178902Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178919Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178926Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178933Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178940Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178957Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178964Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178971Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178988Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178995Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523179008Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523179015Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523179022Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523179039Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523179046Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523179053Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523179060Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523179077Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523179084Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
08800322740446Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740453Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740460Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740477Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740484Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740491Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740507Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23