FDA.reportPublic FDA data

Response 5.5/6.0

Primary DI
00840194498111
Brand
Response 5.5/6.0
Company
ORTHOPEDIATRICS CORP.
Model
00-1750-3300
Catalog number
00-1750-3300
Device description
Response 5.5/6.0 Open-Open Inline Connector
Published
2025-12-26
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
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
K181390000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181390000Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.2018-09-18NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840194498111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194498111008401944981118401944981110840194498111

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system connectorAn implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.

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
Combination product
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00841132125014General Instrument01-1003-300101-1003-30012016-09-25
00841132125021General Instrument01-1003-300201-1003-30022016-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000859404CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-07-18
00763000910365CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-07-18
20763000910376CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-07-18
18257200054206SFSOrthofix US LLCNKB2026-07-17
18257200054213SFSOrthofix US LLCNKB2026-07-17
18257200054220SFSOrthofix US LLCNKB2026-07-17
18257200054237SFSOrthofix US LLCNKB2026-07-17
18257200054244SFSOrthofix US LLCNKB2026-07-17
18257200054251SFSOrthofix US LLCNKB2026-07-17
18257200054268SFSOrthofix US LLCNKB2026-07-17
18257200054275SFSOrthofix US LLCNKB2026-07-17
18257200054282SFSOrthofix US LLCNKB2026-07-17
18257200054299SFSOrthofix US LLCNKB2026-07-17
18257200054305SFSOrthofix US LLCNKB2026-07-17
18257200054312SFSOrthofix US LLCNKB2026-07-17
10840642134797Salvo® Spine SystemSpine Wave, Inc.NKB2026-07-16
00840493424712RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424729RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424736RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424743RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424750RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424767RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424774RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424781RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424798RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424804RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424811RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424828RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424835RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424842RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13