FDA.report

AMP-LTX

Primary DI
00190376515212
Brand
AMP-LTX
Company
ALPHATEC SPINE, INC.
Model
612-50-55
Device description
Lateral Bone Screw, 5.0 x 55mm
Published
2023-04-27
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

Related Records

Product Codes

CodeName
OVDIntervertebral fusion device with integrated fixation, lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions

SubmissionSupplement
K223611000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190376515212PrimaryGS10

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(760)431-9286Regulatory@alphatecspine.com

Regulatory Flags

DUNS number
602465783
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810141040007Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCOVD2026-03-05
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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
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00840067210741TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
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00840067210765TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210772TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
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00840067210802TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210819TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210826TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210833TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210840TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210857TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210864TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210871TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210888TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
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00840067210949TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210956TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210963TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20