FDA.reportPublic FDA data

BluEX Cervical Expandable Cage System

Primary DI
08809986491053
Brand
BluEX Cervical Expandable Cage System
Company
L&K BIOMED CO. ,LTD.
Model
1417-0507S
Device description
BluEX-C (14 X 17 X 5 mm, 7 °)
Published
2026-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260840000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260840000BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.2026-05-16ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809986491053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809986491053088099864910538809986491053

Regulatory Flags#

DUNS number
631159324
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809986489814LnK Spinal Instrument SystemCM138-XTP01-185506062026-11-05
08809986489821LnK Spinal Instrument SystemCM138-XTP01-185508062026-11-05
08809986489838LnK Spinal Instrument SystemCM138-XTP01-185510062026-11-05
08809986489845LnK Spinal Instrument SystemXTP01-18550606C012026-11-05
08809986489852LnK Spinal Instrument SystemXTP01-18550806C012026-11-05
08809986489869LnK Spinal Instrument SystemXTP01-18551006C012026-11-05
08809986489876LnK Spinal Instrument SystemLC04-1207SC022026-11-05
08809986489883LnK Spinal Instrument SystemLC04-1207SC032026-11-05
08809986489890LnK Spinal Instrument SystemLC04-1207SC042026-11-05
08809986489906LnK Spinal Instrument SystemLP01-0603C012026-11-05
08809986487339CastleLoc Pectus Bar SystemBC05-014092025-10-29
08809986487360CastleLoc Pectus Bar SystemBC05-01752025-10-24
08809986485137CastleLoc Pectus Bar SystemOB30-91852026-10-29
08809986485144CastleLoc Pectus Bar SystemOB30-91902026-10-29
08809986485151CastleLoc Pectus Bar SystemOB30-91952026-10-29
08809986485168CastleLoc Pectus Bar SystemOB30-92002026-10-29
08809986485274CastleLoc Pectus Bar SystemWB28-61002026-10-29
08809986485281CastleLoc Pectus Bar SystemWB28-61052026-10-29
08809986485298CastleLoc Pectus Bar SystemWB28-61102026-10-29
08809986485304CastleLoc Pectus Bar SystemWB28-61152026-10-29

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B678522207S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
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B678522209S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522210S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522211S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522212S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522213S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522214S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522215S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522216S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522201S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-29
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B678522203S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-29
B678522204S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-29
B678522205S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-29
B678522206S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-29
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00810017913770Saber-C Body (PT), 14x15x6 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913787Saber-C Body (PT), 14x15x7 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913794Saber-C Body (PT), 14x15x8 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913800Saber-C Body (PT), 14x15x9 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913817Saber-C Body (PT), 14x15x10 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913824Saber-C Body (PT), 14x15x5 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913930Saber-C Body (PT), 14x17x10 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913947Saber-C Body (PT), 14x17x5 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
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00810017913992Saber-C Body (PT), 14x17x10 9 deg.ELEVATION SPINE, INC.ODP2026-10-26