FDA.reportPublic FDA data

Response Rib and Pelvic System

Primary DI
00840194428682
Brand
Response Rib and Pelvic System
Company
ORTHOPEDIATRICS CORP.
Model
01-1600-6100
Catalog number
01-1600-6100
Device description
Rib Prep Tool - 90 Degree
Published
2024-01-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840194428682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194428682008401944286828401944286820840194428682

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation implant alignment toolA surgical instrument designed to facilitate the correct orientation (alignment) of an orthopaedic fixation implant, implants, or system of implants during orthopaedic surgery. It may be used, e.g., to align a series of bone screws in an implant system for posterior stabilization of the spine, or to align a spinal anatomical fixation implant. It is available in a variety of shapes and sizes and allows the surgeon to engage this device with the implant(s) and align them in the desired configuration. It is typically made of high-grade stainless steel or titanium alloy and will have profiled features to fit into the implant(s) to align them. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
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
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00763000754730N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00763000754747N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00822409082124N/AOrtho Development CorporationLXH2026-07-16
00822409082131N/AOrtho Development CorporationLXH2026-07-16
00822409082148N/AOrtho Development CorporationLXH2026-07-16
00822409082155N/AOrtho Development CorporationLXH2026-07-16
00822409082162N/AOrtho Development CorporationLXH2026-07-16
00822409082179N/AOrtho Development CorporationLXH2026-07-16
00822409082186N/AOrtho Development CorporationLXH2026-07-16
00822409082193N/AOrtho Development CorporationLXH2026-07-16
00822409082209N/AOrtho Development CorporationLXH2026-07-16
00822409082216N/AOrtho Development CorporationLXH2026-07-16
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00822409082346N/AOrtho Development CorporationLXH2026-07-16
00840606188135Ventana ASPINAL ELEMENTS, INC.LXH2026-07-16
00840606188142Ventana ASPINAL ELEMENTS, INC.LXH2026-07-16
00840606188159Ventana ASPINAL ELEMENTS, INC.LXH2026-07-16