FDA.reportPublic FDA data

LOSPA IS Spinal System

Primary DI
08800017220185
Brand
LOSPA IS Spinal System
Company
Corentec Co., Ltd
Model
SM.C58.4518
Device description
ACP Fixed Screw, Drilling (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
08800017220185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800017220185088000172201858800017220185

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
08809945895311EXULT Special Instrument(CM)KZ.026.Z0032026-10-15
08809945895328EXULT Special Instrument(CM)KZ.026.Z0122026-10-15
08809945895335EXULT Special Instrument(CM)KZ.026.Z0112026-10-15
08809945895342EXULT Special Instrument(CM)KZ.026.Z0102026-10-15
08809945895359EXULT Special Instrument(CM)KZ.026.Z0092026-10-15
08809945895366EXULT Special Instrument(CM)KZ.026.Z0082026-10-15
08809945895373EXULT Special Instrument(CM)KZ.026.Z0072026-10-15
08809945895380EXULT Special Instrument(CM)KZ.026.Z0062026-10-15
08809945895397EXULT Special Instrument(CM)KZ.026.Z0052026-10-15
08809945895403EXULT Special Instrument(CM)KZ.026.Z0042026-10-15
08800068958112BENCOX THR SystemHA.0C3.02842021-07-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000786458CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-15
10889981217204MeridianSeaspine Orthopedics CorporationKWQ2022-08-25
10889981230838RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981230845RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981230852RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981230869RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981230876RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981230883RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981230890RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981231040RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981231057RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981231064RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981231071RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981231088RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981214289MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214296MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214302MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214319MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214326MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214333MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214340MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214357MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214364MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214371MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214388MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214494MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214500MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214517MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214524MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214531MeridianSeaspine Orthopedics CorporationKWQ2020-12-30