FDA.reportPublic FDA data

NA

Primary DI
10705034734231
Brand
NA
Company
Synthes GmbH
Model
04.601.000
Catalog number
04601000
Device description
90 DEG TI S-HOOK/RIGHT
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDIProsthesis, rib replacement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDIProsthesis, Rib ReplacementOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142587000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142587000Vertical Expandable Prosthetic Titanium RibDepuy Synthes Spine, Inc.2014-11-18MDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034734231PrimaryGS10
H981046010000SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503473423110705034734231

GMDN Terms#

Term, Definition table
TermDefinition
Vertical expandable prosthetic rib systemAn assembly of implantable devices designed to treat a patient with complex chest wall and/or spinal deformities, typically thoracic insufficiency syndrome (TIS) in paediatric patients (a congenital condition where severe deformities of the chest, spine, and ribs prevent normal breathing and lung growth and development). The assembly typically consists of telescoping rods/bars, fixation hooks, and locking screws/clamps made of surgical stainless steel or titanium (Ti), and are typically vertically attached to the ribs, spine, and/or pelvis to help straighten the spine and separate ribs so that the lungs can grow and fill with sufficient air for breathing.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034717081Zero-P03.617.792036177922015-09-14
10705034717098Zero-P03.617.795036177952015-09-14
10705034717203NA03.617.907036179072015-09-14
10705034722634NA03.804.512S03804512S2019-08-10
10705034731841NA03.820.159S03820159S2019-08-10
10705034736075USS04.607.038046070382015-09-14
10705034742199Zero-P04.617.232S04617232S2015-09-14
10705034754444OPAL08.803.114088031142015-09-14
10705034754468OPAL08.803.116088031162015-09-14
10705034754529OPAL08.803.134088031342015-09-14
10705034754611OPAL08.803.214088032142015-09-14
10705034754635OPAL08.803.216088032162015-09-14
10705034754697OPAL08.803.234088032342015-09-14
10705034754741VERTEBRAL SPACER-TR08.804.037088040372015-09-14
10705034754765VERTEBRAL SPACER-TR08.804.039088040392015-09-14
10705034754826VERTEBRAL SPACER-TR08.804.047088040472015-09-14
10705034762852ACIS08.843.805088438052015-09-14
10705034762876ACIS08.843.806088438062015-09-14
10705034762890ACIS08.843.807088438072015-09-14
10705034762913ACIS08.843.808088438082015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840194498968Response Spine SystemORTHOPEDIATRICS CORP.MDI2026-01-29
00840194420006Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194420013Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194420037Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194420044Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422024Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422031Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422048Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422055Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422079Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422086Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422109Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422116Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422123Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422130Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422147Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422161Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422178Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422185Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422192Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422208Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422215Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422222Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194422239Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194428163Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194428330Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194428347Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194428354Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194428378Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
10705034734248NASynthes GmbHMDI2015-09-14