FDA.reportPublic FDA data

LOSPA IS Spinal System

Primary DI
08806373870460
Brand
LOSPA IS Spinal System
Company
Corentec Co., Ltd
Model
SI.C50.0015
Device description
PLIF HOLDER STRAIGHT OUS TYPE
Published
2018-02-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151408000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151408000LOSPA IS Spinal SystemCorentec Co., Ltd.2015-10-02MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806373870460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806373870460088063738704608806373870460

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an orthopaedic implant (e.g., bone screw, bone graft), trial implant, or sizer (e.g., glenoid defect sizer) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during an orthopaedic surgical intervention. The instrument is typically made of high-grade stainless steel or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end (e.g., a threaded portion or a clamp mechanism). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+820415857114hckoh@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
08800017271088BENCOXHA.02F.00012026-05-06
08800017261294EXULT Knee Replacement SystemK3.IAN.4266-09T2020-01-10
08800017261300EXULT Knee Replacement SystemK3.IAN.4266-10T2020-01-10
08800017261317EXULT Knee Replacement SystemK3.IAN.4266-11T2020-01-10
08800017261324EXULT Knee Replacement SystemK3.IAN.4266-12T2020-01-10
08800017261331EXULT Knee Replacement SystemK3.IAN.4266-13T2020-01-10
08800017261348EXULT Knee Replacement SystemK3.IAN.4266-14T2020-01-10
08800017261355EXULT Knee Replacement SystemK3.IAN.4266-16T2020-01-10
08800017261362EXULT Knee Replacement SystemK3.IAN.4266-18T2020-01-10
08800017261379EXULT Knee Replacement SystemK3.IAN.4469-09T2020-01-10
08800017261386EXULT Knee Replacement SystemK3.IAN.4469-10T2020-01-10
08800017261393EXULT Knee Replacement SystemK3.IAN.4469-11T2020-01-10
08800017261409EXULT Knee Replacement SystemK3.IAN.4469-12T2020-01-10
08800017261416EXULT Knee Replacement SystemK3.IAN.4469-13T2020-01-10
08800017261423EXULT Knee Replacement SystemK3.IAN.4469-14T2020-01-10
08800017261430EXULT Knee Replacement SystemK3.IAN.4469-16T2020-01-10
08800017261447EXULT Knee Replacement SystemK3.IAN.4469-18T2020-01-10
08800017261454EXULT Knee Replacement SystemK3.IAN.4572-09T2020-01-10
08800017261461EXULT Knee Replacement SystemK3.IAN.4572-10T2020-01-10
08800017261478EXULT Knee Replacement SystemK3.IAN.4572-11T2020-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800043966040N/ATDM Co., Ltd.MAX2026-06-08
08800043966057N/ATDM Co., Ltd.MAX2026-06-08
08800043966064N/ATDM Co., Ltd.MAX2026-06-08
08800043966071N/ATDM Co., Ltd.MAX2026-06-08
08800043966088N/ATDM Co., Ltd.MAX2026-06-08
08800043966095N/ATDM Co., Ltd.MAX2026-06-08
08800043966101N/ATDM Co., Ltd.MAX2026-06-08
08800043966118N/ATDM Co., Ltd.MAX2026-06-08
08800043966125N/ATDM Co., Ltd.MAX2026-06-08
08800043966132N/ATDM Co., Ltd.MAX2026-06-08
08800043966149N/ATDM Co., Ltd.MAX2026-06-08
08800043966156N/ATDM Co., Ltd.MAX2026-06-08
08800043966163N/ATDM Co., Ltd.MAX2026-06-08
08800043966170N/ATDM Co., Ltd.MAX2026-06-08
08800043966187N/ATDM Co., Ltd.MAX2026-06-08
08800043966194N/ATDM Co., Ltd.MAX2026-06-08
08800043966200N/ATDM Co., Ltd.MAX2026-06-08
08800043966217N/ATDM Co., Ltd.MAX2026-06-08
08800043966224N/ATDM Co., Ltd.MAX2026-06-08
08800043966231N/ATDM Co., Ltd.MAX2026-06-08
08800043966248N/ATDM Co., Ltd.MAX2026-06-08
08800043966255N/ATDM Co., Ltd.MAX2026-06-08
08800043966262N/ATDM Co., Ltd.MAX2026-06-08
08800043966279N/ATDM Co., Ltd.MAX2026-06-08
08800043966286N/ATDM Co., Ltd.MAX2026-06-08
08800043966293N/ATDM Co., Ltd.MAX2026-06-08
08800043966309N/ATDM Co., Ltd.MAX2026-06-08
08800043966316N/ATDM Co., Ltd.MAX2026-06-08
08800043966323N/ATDM Co., Ltd.MAX2026-06-08
08800043966330N/ATDM Co., Ltd.MAX2026-06-08