FDA.reportPublic FDA data

LOSPA IS Spinal System

Primary DI
08806373836961
Brand
LOSPA IS Spinal System
Company
Corentec Co., Ltd
Model
01.21.069
Device description
Rod-B
Published
2015-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
08806373836961PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806373836961088063738369618806373836961

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system rodAn implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder 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)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+82269374902ra@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
08800017262819EXULT Knee Replacement SystemK3.IBN.4063-09T2020-01-10
08800017262826EXULT Knee Replacement SystemK3.IBN.4063-10T2020-01-10
08800017262833EXULT Knee Replacement SystemK3.IBN.4063-11T2020-01-10
08800017262840EXULT Knee Replacement SystemK3.IBN.4063-12T2020-01-10
08800017262857EXULT Knee Replacement SystemK3.IBN.4063-13T2020-01-10
08800017262864EXULT Knee Replacement SystemK3.IBN.4063-14T2020-01-10
08800017262871EXULT Knee Replacement SystemK3.IBN.4063-16T2020-01-10
08800017262888EXULT Knee Replacement SystemK3.IBN.4063-18T2020-01-10
08800017262895EXULT Knee Replacement SystemK3.IBN.4266-09T2020-01-10
08800017262901EXULT Knee Replacement SystemK3.IBN.4266-10T2020-01-10
08800017262918EXULT Knee Replacement SystemK3.IBN.4266-11T2020-01-10
08800017264899EXULT Knee Replacement SystemK3.IBN.3860-22T2020-01-10
08800017264905EXULT Knee Replacement SystemK3.IBN.3860-24T2020-01-10
08800017264912EXULT Knee Replacement SystemK3.IBN.4063-20T2020-01-10
08800017264929EXULT Knee Replacement SystemK3.IBN.4063-22T2020-01-10
08800017264936EXULT Knee Replacement SystemK3.IBN.4063-24T2020-01-10
08800068960467BENCOXHA.0CC.00012026-06-09
08806373886355BENCOX01.51.8022026-06-09
08806373899997BENCOXHA.02A.00012026-06-09
08809945870578BENCOXHA.02M.00022026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-06-28
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-06-28
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-06-28
00810017913893Saber-C Body (PT), 14x17x6 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017913909Saber-C Body (PT), 14x17x7 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017913916Saber-C Body (PT), 14x17x8 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017913923Saber-C Body (PT), 14x17x9 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914357Saber-C Plate, 12x15x5 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914364Saber-C Plate, 12x15x6 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914371Saber-C Plate, 12x15x7 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914388Saber-C Plate, 12x15x8 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914395Saber-C Plate, 12x15x9 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914401Saber-C Plate, 12x15x10 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914630Saber-C Plate, 14x17x9 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
10889981065348MarinerSeaspine Orthopedics CorporationKWQ2016-09-02
10889981065348MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065348MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065539MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981005115NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005115NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005139NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005139NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005146NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005146NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005290NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005290NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005306NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005306NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005313NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005313NewportSeaspine Orthopedics CorporationMNH2015-09-24