FDA.report

Response Rib and Pelvic System

Primary DI
00840194420044
Brand
Response Rib and Pelvic System
Company
ORTHOPEDIATRICS CORP.
Model
00-1600-3905
Catalog number
00-1600-3905
Device description
PELVIC SADDLE WITH ROD, 17.5
Published
2024-01-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
MDIProsthesis, rib replacement

Product Code Classifications

CodeDeviceSpecialtyClass
MDIProsthesis, Rib ReplacementOrthopedic2

Premarket Submissions

SubmissionSupplement
K233105000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K233105000RESPONSE™ Rib and Pelvic SystemOrthoPediatrics Corp.2024-01-20MDI

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840194420044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194420044008401944200448401944200440840194420044

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
796416191
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840194498975Response 5.5/6.001-1300-935001-1300-93502026-03-03
00840194498982Response 5.5/6.001-1300-936001-1300-93602026-03-03
00840536800244Response 5.5/6.001-1300-913501-1300-91352026-03-03
00840536800251Response 5.5/6.001-1300-913601-1300-91362026-03-03
00840194499194Contracture ManagementNS-6000-3001NS-6000-30012026-03-02
00840194499200Contracture ManagementNS-6000-3002NS-6000-30022026-03-02
00840194499217Contracture ManagementNS-6000-3003NS-6000-30032026-03-02
00840194499224Contracture ManagementNS-6000-3004NS-6000-30042026-03-02
00840194499231Contracture ManagementNS-6000-3005NS-6000-30052026-03-02
00840194499248Contracture ManagementNS-6000-4001NS-6000-40012026-03-02
00840194499255Contracture ManagementNS-6000-4101NS-6000-41012026-03-02
00840194499262Contracture ManagementNS-6000-4002NS-6000-40022026-03-02
00840194499279Contracture ManagementNS-6000-4102NS-6000-41022026-03-02
00840194498968Response Spine System01-1600-559001-1600-55902026-01-29
00840194498128Response Spine System01-1300-091001-1300-09102026-01-22
00840194498043Response Spine System01-1300-551601-1300-55162026-01-15
00840194498050Response Spine System01-1300-551701-1300-55172026-01-15
00840194498944Response 5.5/6.001-1300-607301-1300-60732026-01-15
00840194498951Response 5.5/6.001-1300-607401-1300-60742026-01-15
00840536800237Response Spine System01-1700-028001-1700-02802026-01-15

Other Devices Sharing Product Codes

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
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
00840194428385Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25
00840194428392Response Rib and Pelvic SystemORTHOPEDIATRICS CORP.MDI2024-01-25