FDA.report

LOSPA IS Spinal System

Primary DI
08800068943422
Brand
LOSPA IS Spinal System
Company
Corentec Co., Ltd
Model
217100050
Device description
Distraction blade,right,110mm
Published
2022-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800068943422PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800068943422088000689434228800068943422

GMDN Terms

TermDefinition
Human herpesvirus 7 (HHV7) antigen IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from Human herpesvirus 7 (HHV7) in a clinical specimen.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+82415857114sungwon.yang@corentec.com

Regulatory Flags

DUNS number
688739895
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08809945895076EXULT Surgical InstrumentKZ.024.Z0232026-03-23
08806373887703BENCOX Surgical Instruments01.51.7532026-02-23
08809945895021EXULT Surgical InstrumentKZ.024.Z0182026-02-20
08809945895038EXULT Surgical InstrumentKZ.024.Z0192026-02-20
08809945895045EXULT Surgical InstrumentKZ.024.Z0202026-02-20
08809945895052EXULT Surgical InstrumentKZ.024.Z0212026-02-20
08809945895069EXULT Surgical InstrumentKZ.024.Z0222026-02-20
08809945895083EXULT Surgical InstrumentKZ.024.Z0242026-02-20
08809945895090EXULT Surgical InstrumentKZ.024.Z0252026-02-20
08809945895106EXULT Surgical InstrumentKZ.024.Z0262026-02-20
08809945895113EXULT Surgical InstrumentKZ.024.Z0272026-02-20
08809945895120EXULT Surgical InstrumentKZ.024.Z0282026-02-20
08800017271101Bencox Hip SystemHA.02J.00012018-11-21
08800017278230Bencox Hip SystemHZ.012.00012018-11-22
08800017285405Bencox Hip SystemHA.0B2.00012018-11-22
08800017299358BENCOX Surgical Instruments01.51.771.062026-01-12
08806373874215Bencox Hip SystemHA.013.00042018-11-21
08806373887734BENCOX Surgical Instruments01.51.7712026-01-12
08806373887826BENCOX Surgical Instruments01.51.8882026-01-12
08806373887833BENCOX Surgical Instruments01.51.888.012026-01-12

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04048844738150implaFit®implantcast GmbHLXH2026-03-24
07630542779244Surgical Manual InstrumentMedacta International SALXH2026-03-24
08053782783656BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783663BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783670BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783687BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783694BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783700BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783748TOOL VIP XL Instruments KitBRM EXTREMITIES SRLLXH2026-03-24
10888857596986K2M General InstrumentsK2M, INC.LXH2026-03-24
10888857596993K2M General InstrumentsK2M, INC.LXH2026-03-24
24026704941630PILLINGTELEFLEX INCORPORATEDLXH2026-03-23
00199150044016Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150067343Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150043989Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150043996Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150044009Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00198506089718ELMED INCORPORATEDELMED INCORPORATEDLXH2026-03-20
00810166520003X-PACEXPANDING INNOVATIONS, INC.LXH2026-03-20
00840314270221gSourceGSOURCE LLCLXH2026-03-20
00840314270238gSourceGSOURCE LLCLXH2026-03-20
10705034577678N/AMedos International SàrlLXH2026-03-20
00190446898801Arsenal FootTrilliant Surgical, LLCLXH2026-03-19
008890247065832 Piece Modular Shell Adapter BoltZimmer, Inc.LXH2026-03-19
008890247065902 Piece Modular Shell AdapterZimmer, Inc.LXH2026-03-19
03700879518589PECAPLASTY®NOVASTEPLXH2026-03-19
03700879518596PECAPLASTY®NOVASTEPLXH2026-03-19
07630542789984Surgical Manual InstrumentMedacta International SALXH2026-03-19
07630542789991Surgical Manual InstrumentMedacta International SALXH2026-03-19
07630542797576Surgical Manual InstrumentMedacta International SALXH2026-03-19