FDA.reportPublic FDA data

LOSPA IS Spinal Fixation System

Primary DI
08800017247465
Brand
LOSPA IS Spinal Fixation System
Company
Corentec Co., Ltd
Model
SA.222.8517
Device description
MONOAXIAL GUIDED PEDICLE SCREW II - Guided type Ø8.5 X 135, Length 163.9mm
Published
2020-03-23
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
08800017247465PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800017247465088000172474658800017247465

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
08800017276182LOSPAKA.STA.00132026-10-29
08806373878039LOSPAKB.STC.00102026-10-29
08806373889653LOSPA01.61.1702026-10-29
08806373894190LOSPA01.61.1212026-10-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157124618ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124625ZAVATION SCREWZavation LLCNKB2026-11-04
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00197157124670ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124687ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124694ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124700ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124717ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124724ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124731ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124748ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124755ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124762ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124779ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124786ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124793ZAVATION SCREWZavation LLCNKB2026-11-04
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00197157124823ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124830ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124847ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124854ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124861ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124878ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124885ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124892ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124908ZAVATION SCREWZavation LLCNKB2026-11-04