FDA.reportPublic FDA data

LOSPA IS Spinal System

Primary DI
08800017220055
Brand
LOSPA IS Spinal System
Company
Corentec Co., Ltd
Model
SM.C57.4016
Device description
ACP Fixed Screw, Self-Tapping (Sterile)
Published
2017-04-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161641000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161641000LOSPA IS ACP SystemCorentec Co., Ltd.2017-01-05KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800017220055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800017220055088000172200558800017220055

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+82269374902ra@corentec.com

Regulatory Flags#

DUNS number
688739895
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
08800017260860EXULT Knee Replacement SystemK3.BFN.38602020-01-10
08800017260877EXULT Knee Replacement SystemK3.BFN.40632020-01-10
08800017260884EXULT Knee Replacement SystemK3.BFN.42662020-01-10
08800017260891EXULT Knee Replacement SystemK3.BFN.44692020-01-10
08800017260907EXULT Knee Replacement SystemK3.BFN.45722020-01-10
08800017260914EXULT Knee Replacement SystemK3.BFN.47752020-01-10
08800017260921EXULT Knee Replacement SystemK3.BFN.50792020-01-10
08800017260938EXULT Knee Replacement SystemK3.BFN.53832020-01-10
08800017260945EXULT Knee Replacement SystemK3.BFN.57862020-01-10
08800017260952EXULT Knee Replacement SystemK3.BFU.36572020-01-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810017914555Saber-C Body (PT), 14x17x8 12 deg.ELEVATION SPINE, INC.KWQ2026-07-23
00810017914562Saber-C Body (PT), 14x17x7 12 deg.ELEVATION SPINE, INC.KWQ2026-07-23
00810017914579Saber-C Body (PT), 14x17x9 12 deg.ELEVATION SPINE, INC.KWQ2026-07-23
00810017914586Saber-C Body (PT), 14x17x10 12 deg.ELEVATION SPINE, INC.KWQ2026-07-23
00810017914647Saber-C Plate, 14x17x10 12 deg.ELEVATION SPINE, INC.KWQ2026-07-23
00840466901035PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901042PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
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