FDA.report

LOSPA IS Spinal System

Primary DI
08800017278155
Brand
LOSPA IS Spinal System
Company
Corentec Co., Ltd
Model
20308203
Device description
DLIF pin 11cm
Published
2022-10-21
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

Contact Domains

Product Codes

CodeName
HXQCrimper, Pin

Product Code Classifications

CodeDeviceSpecialtyClass
HXQCrimper, PinOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800017278155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800017278155088000172781558800017278155

GMDN Terms

TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+82415857114sungwon.yang@corentec.com

Regulatory Flags

DUNS number
688739895
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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