FDA.reportPublic FDA data

XULTAN 5.5 PEDICLE SCREW 4.5 X 70 MM NON-CANN

Primary DI
00819824021012
Brand
XULTAN 5.5 PEDICLE SCREW 4.5 X 70 MM NON-CANN
Company
MET 1 TECHNOLOGIES, LLC
Model
50457000
Catalog number
50457000
Device description
THE XULTAN 5.5 PEDICLE SCREW SYSTEM IS AN IMPLANT DEVICE MANUFACTURED FROM TITANIUM AND SILICONE. THE SCREWS ARE AVAILABLE CANNULATED OR NON-CANNULATED IN VARIOUS DIAMETERS AND LENGTHS TO ACCOMMODATE VARIOUS PATIENT ANATOMIES. THE SYSTEM INCLUDES STRAIGHT RODS, CURVED RODS, CROSSLINKS, AND ASSOCIATED INSTRUMENTATION.
Published
2018-03-28
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
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170108000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170108000Xultan 5.5 Pedicle Screw SystemMet One Technologies2017-05-02NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819824021012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819824021012008198240210128198240210120819824021012

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
9154726762yone@met1tech.com

Regulatory Flags#

DUNS number
080474650
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819824024129CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL60010012600100122019-03-06
00819824024136CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL60010014600100142019-03-06
00819824024143CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL60010016600100162019-03-06
00819824024150CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL60010018600100182019-03-06
00819824024167CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL60010020600100202019-03-06
00819824024174CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL60010022600100222019-03-06
00819824024181CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL60010024600100242019-03-06
00819824024198CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020024600200242019-03-06
00819824024204CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020026600200262019-03-06
00819824024211CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020028600200282019-03-06
00819824024228CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020030600200302019-03-06
00819824024235CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020032600200322019-03-06
00819824024242CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020034600200342019-03-06
00819824024259CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020037600200372019-03-06
00819824024266CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020040600200402019-03-06
00819824024273CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020043600200432019-03-06
00819824024280CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020046600200462019-03-06
00819824024297CZAR ANTERIOR CERVICAL PLATE SYSTEM 3 LEVEL60030039600300392019-03-06
00819824024303CZAR ANTERIOR CERVICAL PLATE SYSTEM 3 LEVEL60030042600300422019-03-06
00819824024310CZAR ANTERIOR CERVICAL PLATE SYSTEM 3 LEVEL60030045600300452019-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-06-28
10889981441555VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441609VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441616VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441623VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441661VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981065348MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065539MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065553MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065577MarinerSeaspine Orthopedics CorporationNKB2016-09-02
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10889981065683MarinerSeaspine Orthopedics CorporationNKB2016-09-02
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10889981065744MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065768MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065782MarinerSeaspine Orthopedics CorporationNKB2016-09-02
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10889981065829MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065843MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065867MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065881MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065904MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065928MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065959MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065966MarinerSeaspine Orthopedics CorporationNKB2016-09-02
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