FDA.reportPublic FDA data

Trauma Plate System

Primary DI
00190376525778
Brand
Trauma Plate System
Company
ALPHATEC SPINE, INC.
Model
612-55-40-C
Device description
Lateral Core Graft Bolt, 5.5 x 40 mm
Published
2023-10-05
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
KWQAppliance, fixation, spinal intervertebral body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230721000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230721000ATEC Lateral Plate SystemAlphatec Spine, Inc.2023-05-09KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190376525778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376525778001903765257781903765257780190376525778

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
00190376658933Valence Robotic Navigation System13010-Q-VN2026-10-29
00190376658940Valence Robotic Navigation System13010-VN2026-10-29
00190376659053Valence Robotic Navigation System13110-Q-VN2026-10-29
00190376729374Invictus Spinal Fixation System13603-01-VN2026-10-29
00190376729435Invictus Spinal Fixation System13613-01-VN2026-10-29
00190376749297Valence Robotic Navigation SystemVALPDP2026-10-29
00190376766140Valence Robotic Navigation SystemVNAVSUP2026-10-29
00190376776941Valence Robotic Navigation SystemV2MNVINN2026-10-29
00190376778358Valence Robotic Navigation SystemV2ONVINN2026-10-29
00190376632919Invictus19869-N2026-10-20
00840967110981AlphaGRAFT1002-1002015-09-24
00840967110998AlphaGRAFT1001-0102015-09-24
00840967111001AlphaGRAFT1001-1002015-09-24
00844856026711AlphaGRAFT1001-0502015-09-24
00844856026728AlphaGRAFT1002-0252015-09-24
00844856026735AlphaGRAFT1002-0502015-09-24
00844856032231Osseofix +213902016-10-28
00190376649474CONTOUR3DAIX761032026-09-25
00190376652313CONTOUR3DAIX761012026-09-25
00190376652320CONTOUR3DAIX761022026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000777418CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-11-01
00763000777517CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-11-01
00763000777524CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-11-01
00763000774165CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-31
00763000774172MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-31
00763000774189MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-31
00763000774196MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-31
00763000774202MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-31
00763000774226MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-31
00763000774240MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-31
00763000774257MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-31
00763000774301MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-31
00763000777692MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-31
00763000777739MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-31
00810017916191SABER-XA, Expandable Spacer, 37x28mm, 16mm, (18°)ELEVATION SPINE, INC.KWQ2026-10-27
00810017913763Saber-C Body (PT), 14x15x5 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913770Saber-C Body (PT), 14x15x6 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913787Saber-C Body (PT), 14x15x7 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913794Saber-C Body (PT), 14x15x8 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913800Saber-C Body (PT), 14x15x9 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913817Saber-C Body (PT), 14x15x10 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913824Saber-C Body (PT), 14x15x5 9 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913930Saber-C Body (PT), 14x17x10 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913947Saber-C Body (PT), 14x17x5 9 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913954Saber-C Body (PT), 14x17x6 9 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913961Saber-C Body (PT), 14x17x7 9 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913978Saber-C Body (PT), 14x17x8 9 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913985Saber-C Body (PT), 14x17x9 9 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913992Saber-C Body (PT), 14x17x10 9 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914005Saber-C Body (PT), 15x18x5 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26