FDA.reportPublic FDA data

Response Rib and Pelvic System

Primary DI
00840194422185
Brand
Response Rib and Pelvic System
Company
ORTHOPEDIATRICS CORP.
Model
00-1600-4100
Catalog number
00-1600-4100
Device description
PELVIC LOCKING SCREW, 10.0
Published
2024-01-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

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
K233105000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233105000RESPONSE™ Rib and Pelvic SystemOrthoPediatrics Corp.2024-01-20MDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840194422185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194422185008401944221858401944221850840194422185

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

Regulatory Flags#

DUNS number
796416191
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840536822864Response Spine01-1600-001701-1600-00172026-08-21
00840536822871Response Spine01-1300-011201-1300-01122026-08-21
00840536822888Response Spine01-1300-011301-1300-01132026-08-21
00840536822895Response Spine01-1300-611501-1300-61152026-08-21
00840536822901Response Spine01-1300-611601-1300-61162026-08-21
00840536824707Response Spine01-1600-607301-1600-60732026-08-21
00840536824974PedFlex Flexible Nailing System00-1001-1015-S00-1001-1015-S2026-08-14
00840536824981PedFlex Flexible Nailing System00-1001-1020-S00-1001-1020-S2026-08-14
00840536824998PedFlex Flexible Nailing System00-1001-1025-S00-1001-1025-S2026-08-14
00840536825001PedFlex Flexible Nailing System00-1001-1030-S00-1001-1030-S2026-08-14
00840536825018PedFlex Flexible Nailing System00-1001-1035-S00-1001-1035-S2026-08-14
00840536825025PedFlex Flexible Nailing System00-1001-1040-S00-1001-1040-S2026-08-14
00840536825032PedFlex Flexible Nailing System00-1001-1115-S00-1001-1115-S2026-08-14
00840536825049PedFlex Flexible Nailing System00-1001-1120-S00-1001-1120-S2026-08-14
00840536825056PedFlex Flexible Nailing System00-1001-1125-S00-1001-1125-S2026-08-14
00840536825063PedFlex Flexible Nailing System00-1001-1130-S00-1001-1130-S2026-08-14
00840536825070PedFlex Flexible Nailing System00-1001-1135-S00-1001-1135-S2026-08-14
00840536825087PedFlex Flexible Nailing System00-1001-1140-S00-1001-1140-S2026-08-14
00840536825094PedFlex Flexible Nailing System00-1001-1145-S00-1001-1145-S2026-08-14
00840194499248Contracture ManagementNS-6000-4001NS-6000-40012026-03-02

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
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
10705034734231NASynthes GmbHMDI2015-09-14
10705034734248NASynthes GmbHMDI2015-09-14