FDA.reportPublic FDA data

Response Spine System

Primary DI
00840194498968
Brand
Response Spine System
Company
ORTHOPEDIATRICS CORP.
Model
01-1600-5590
Catalog number
01-1600-5590
Device description
Response Modular Counter Torque, Rib Clamp
Published
2026-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDIProsthesis, rib replacement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDIProsthesis, Rib ReplacementOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840194498968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194498968008401944989688401944989680840194498968

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic counter-torque/rod-pushing instrumentA hand-held, manual, tube-like surgical instrument with a right-angled handle designed to apply a rotational force that opposes the directional force of torque when tightening (locking) a screw or screw head setscrew with a screwdriver, inserted down the instrument's hollow centre, during orthopaedic surgery. In addition, it may be used to push (seat) an orthopaedic rod into the slotted screw heads of screws that have been inserted into bone (e.g., vertebrae). It is typically made of high-grade stainless steel or titanium alloy, and synthetic materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(574)268-6379xxx@xxx.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840536823717VerteGlide Spinal Growth Guidance System03-1721-450303-1721-45032026-07-24
00840536823724VerteGlide Spinal Growth Guidance System03-1723-550303-1723-55032026-07-24
00841132133200PediFlex01-1000-00101-1000-0012017-02-15
00841132133217PediFlex01-1000-00201-1000-0022017-02-15
00841132135280PediNail21-1500-00721-1500-0072017-02-15
00841132135297PediNail21-1500-01021-1500-0102017-02-15
00841132135303PediNail21-1500-01221-1500-0122017-02-15
00841132135310PediNail21-1500-01321-1500-0132017-02-15
00841132135334PediNail21-1500-01921-1500-0192017-02-15
00841132135341PediNail21-1500-11221-1500-1122017-02-15
00841132135358PediNail21-1500-11921-1500-1192017-02-15
00841132135372PediNail21-1500-911321-1500-91132017-02-15
00841132135389PediNail21-1500-921321-1500-92132017-02-15
00841132135396PediNail21-1500-921421-1500-92142017-02-15
00841132179833Vilex ToolP460-45-100P460-45-1002020-03-02
00841132179888Orthex ToolPP460-15-110PP460-15-1102020-03-02
00841132142325eZ-Fix500-G500-G2020-02-28
00841132142905eZ-Fix900-CW-14900-CW-142020-02-28
00841132142950eZ-Fix900-TW-30900-TW-302020-02-28
00841132143025eZ-Fix925-TW-30925-TW-302020-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10705034734231NASynthes GmbHMDI2015-09-14
10705034734248NASynthes GmbHMDI2015-09-14