FDA.reportPublic FDA data

Contact ALP

Primary DI
00840311233137
Brand
Contact ALP
Company
Xtant Medical Holdings, Inc.
Model
25-SP-50
Device description
50mm Anterior Sacral Plate
Published
2023-06-09
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
K090222000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090222000PIONEER LUMBAR PLATE SYSTEMPioneer Surgical Technology2009-04-28KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840311233137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840311233137008403112331378403112331370840311233137

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(844)894-7752customerservice@surgalign.com

Regulatory Flags#

DUNS number
081224143
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
00840311245390Streamline® MIS Spinal Fixation System04-CANNTAP-4004-CANNTAP-402026-03-18
00840311245406Streamline® MIS Spinal Fixation System04-CANNTAP-4504-CANNTAP-452026-03-18
00840311245437Streamline® MIS Spinal Fixation System04-CANNTAP-7504-CANNTAP-752026-03-18
00840311245642Streamline® MIS Spinal Fixation System04-RDSETSCR-INS04-RDSETSCR-INS2026-03-18
00840311245703Streamline® MIS Spinal Fixation System04-SEQDILATOR-104-SEQDILATOR-12026-03-18
00840311245710Streamline® MIS Spinal Fixation System04-SEQDILATOR-204-SEQDILATOR-22026-03-18
00840311245727Streamline® MIS Spinal Fixation System04-SEQDILATOR-304-SEQDILATOR-32026-03-18
00840311245734Streamline® MIS Spinal Fixation System04-SEQDILATOR-404-SEQDILATOR-42026-03-18
00840311245741Streamline® MIS Spinal Fixation System04-SETSCREWINS04-SETSCREWINS2026-03-18
00840311245925Streamline® MIS Spinal Fixation System05-CT-TUBE05-CT-TUBE2026-03-18
00840311245932Streamline MIS Spinal Fixation System05-DILATOR05-DILATOR2026-04-30
00840311245956Streamline® MIS Spinal Fixation System05-FINALDRIVER05-FINALDRIVER2026-03-18
00840311245963Streamline® MIS Spinal Fixation System05-FINALDRIVER205-FINALDRIVER22026-03-18
00840311246700Streamline® MIS Spinal Fixation System05-TAPSLEEVE05-TAPSLEEVE2026-03-18
00840311246755Streamline MIS Spinal Fixation System51-GW-500-BLUNT51-GW-500-BLUNT2026-04-30
00840311246762Streamline MIS Spinal Fixation System51-GW-500-BLUNT-SS51-GW-500-BLUNT-SS2026-04-30
00840311246779Streamline MIS Spinal Fixation System51-GW-500-BLUNT-TH51-GW-500-BLUNT-TH2026-04-30
00840311246786Streamline MIS Spinal Fixation System51-GW-500-SHARP51-GW-500-SHARP2026-04-30
00840311246793Streamline MIS Spinal Fixation System51-GW-500-SHARP-SS51-GW-500-SHARP-SS2026-04-30
00840311246809Streamline MIS Spinal Fixation System51-GW-500-SHARP-TH51-GW-500-SHARP-TH2026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841732169371TAURUS LX Pedicle Screw SystemCTL Medical CorporationKWQ2026-11-04
08800322699775AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08800322699782AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08800322699799AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08800424704032AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08800424704049AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08800424704056AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885719654AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885719661AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885719678AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885719685AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885719692AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885799939AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885799946AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885799953AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974809969AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974809976AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974809983AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974809990AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819852AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819869AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819876AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819883AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819890AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819906AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819913AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819920AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819937AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819944AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
B06221006200White Pearl Preferred Angle ACPOsseus Fusion Systems, LLCKWQ2017-10-09