FDA.reportPublic FDA data

LOSPA IS Spinal Fixation System

Primary DI
08800017256757
Brand
LOSPA IS Spinal Fixation System
Company
Corentec Co., Ltd
Model
SA.606.7545
Device description
MIS POLYAXIAL PEDICLE SCREW - SHORT Ø7.5 X 45
Published
2020-03-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200267000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200267000LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.2020-03-06NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800017256757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800017256757088000172567578800017256757

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+82414107176sungwon.yang@corentec.com
+82269374902ra@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
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
00197157120962ZAVATION SCREWZavation LLCNKB2026-10-15
00197157120979ZAVATION SCREWZavation LLCNKB2026-10-15
00197157120986ZAVATION SCREWZavation LLCNKB2026-10-15
00197157120993ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121006ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121013ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121020ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121037ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121044ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121051ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121068ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121075ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121082ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121099ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121105ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121112ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121129ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121136ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121143ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121150ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121167ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121174ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121181ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121198ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121204ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121211ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121228ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121235ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121242ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121259ZAVATION SCREWZavation LLCNKB2026-10-15