FDA.report

Response Rib and Pelvic System

Primary DI
00840194428705
Brand
Response Rib and Pelvic System
Company
ORTHOPEDIATRICS CORP.
Model
01-1600-6300
Catalog number
01-1600-6300
Device description
Rib Prep Tool - Curved
Published
2024-01-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840194428705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194428705008401944287058401944287050840194428705

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
796416191
Device count
1
DM exempt
false
Premarket exempt
true
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

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