FDA.reportPublic FDA data

LOSPA IS Spinal System

Primary DI
08800017291871
Brand
LOSPA IS Spinal System
Company
Corentec Co., Ltd
Model
SI.AP6.0041
Device description
ROD ROCKER
Published
2018-12-14
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
KWQAppliance, Fixation, Spinal Intervertebral Body
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092076000
K132644000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092076000AEGIS & AEGIS II SPINAL SYSTEMCorentec Co., Ltd.2010-04-02MNI
K132644000LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BUCorentec Co., Ltd.2013-09-19MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800017291871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800017291871088000172918718800017291871

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic instrument surgical connectorA small device designed to be used during a surgical procedure to make a physical connection between two orthopaedic instruments, instrument components, or an orthopaedic instrument and another device (e.g., an implant) to facilitate the insertion and placement of implantable devices (e.g., pins, nails, screws, blades) into bone or to achieve a procedure goal (e.g., bone fracture compression). It is typically made of metal and in one of several forms (e.g., screw, nut, threaded rod). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+820415857114joonseok.ryoo@corentec.com

Regulatory Flags#

DUNS number
688739895
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800068946966BENCOXHA.018.28352026-07-01
08800068946973BENCOXHA.018.40622026-07-01
08800068963666BENCOXHA.018.36422026-07-01
08806373897344BENCOXHA.018.28372026-07-01
08806373897351BENCOXHA.018.32392026-07-01
08806373897368BENCOXHA.018.36442026-07-01
08806373897375BENCOXHA.018.36482026-07-01
08806373897382BENCOXHA.018.36522026-07-01
08809945870332BENCOX InstrumentHA.014.00042024-04-24
08800068983558BENCOXHA.0B8.00012026-07-24
08800017271095BENCOXHA.02G.00012026-04-10
08800017269726EXULT Knee Replacement SystemK3.FAL.73762020-05-21
08800017269733EXULT Knee Replacement SystemK3.FAR.73762020-05-21
08800017269740EXULT Knee Replacement SystemK3.FAL.76782020-05-21
08800017269757EXULT Knee Replacement SystemK3.FAR.76782020-05-21
08800017269764EXULT Knee Replacement SystemK3.FBL.73762020-05-21
08800017269771EXULT Knee Replacement SystemK3.FBR.73762020-05-21
08800017269788EXULT Knee Replacement SystemK3.FBL.76782020-05-21
08800017269795EXULT Knee Replacement SystemK3.FBR.76782020-05-21
08800017260853EXULT Knee Replacement SystemK3.BFN.36572020-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017915125SABER-XA, Screw Ø5.0 x 22.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.KWQ2026-09-22
10888857598164Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598171Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598188Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598232Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598249Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
00810056993146corraCarlsmed, Inc.KWQ2026-01-30
00613994887955TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-09-17
00613994887955TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2015-09-17
00885074494722TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-08-05
00885074494722TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2015-08-05
00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-08-05
00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2015-08-05
00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2015-08-05
00613994888143TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2015-08-05
00613994888143TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-08-05
04546540147257XIA IIStryker CorporationMNI2014-12-08
04546540147257XIA IIStryker CorporationMNH2014-12-08
04546540147257XIA IIStryker CorporationKWQ2014-12-08