FDA.report

LOSPA IS Spinal Fixation System

Primary DI
08800017259864
Brand
LOSPA IS Spinal Fixation System
Company
Corentec Co., Ltd
Model
SA.M55.0035
Device description
MIS ROD Ø5.5X35 Pre-bent R200
Published
2020-03-23
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications

CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800017259864PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800017259864088000172598648800017259864

GMDN Terms

TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+82414107176sungwon.yang@corentec.com
+82269374902ra@corentec.com

Regulatory Flags

DUNS number
688739895
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00840493418704RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418711RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418728RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418735RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418742RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418759RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418766RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418773RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418780RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418797RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418803RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418810RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418827RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418834RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418841RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418858RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418865RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418872RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418889RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418896RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418902RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418919RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418926RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418933RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418940RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418957RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418964RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418971RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00190837124458ArxLife Spine, Inc.NKB2026-03-23
00190837124465ArxLife Spine, Inc.NKB2026-03-23