FDA.reportPublic FDA data

MaXcess

Primary DI
00887517128478
Brand
MaXcess
Company
Nuvasive, Inc.
Model
3241000
Device description
MaXcess 4 Surgical Access Kit
Published
2021-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSTLIGHT, SURGICAL, FIBEROPTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSTLight, Surgical, FiberopticGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042034000NUVASIVE MAXCESS LIGHT GUIDENuvasive, Inc.2004-10-26FST

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517128478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517128478008875171284788875171284780887517128478

GMDN Terms#

Term, Definition table
TermDefinition
Internal spinal fixation procedure kit, single-useA collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(858)909-1800RA_UDI@nuvasive.com
+1800-475-9131nuvainfo@globusmedical.com

Regulatory Flags#

DUNS number
053950783
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887517377692CoRoent68510122015-10-24
00887517390516CoRoent69102452015-10-24
00195377006424CoRoent6791713P26791713P22026-05-08
00195377006431CoRoent6791712P26791712P22026-05-08
00887517051905CoRoent6791715P26791715P22026-05-08
00887517051912CoRoent6791716P26791716P22026-05-08
00887517051929CoRoent6791812P26791812P22026-05-08
00887517051936CoRoent6791813P26791813P22026-05-08
00887517051943CoRoent6791814P26791814P22026-05-08
00887517051950CoRoent6791815P26791815P22026-05-08
00887517051967CoRoent6791816P26791816P22026-05-08
00887517180513MaXcess32000282022-07-20
00887517063434MaXcess10109872019-11-21
00887517074973MaXcess10254612019-11-21
00887517183323MaXcess32001202019-11-21
00887517183378MaXcess32002202019-11-21
00887517206084MaXcess34000332019-11-21
00887517206572MaXcess34000442019-11-21
00887517497222MaXcess32410022019-11-21
00887517729071MaXcess35000172019-12-04

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Primary DI, Brand, Company table
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00816835024445SYSTEM TWO LEDMedical Illumination International Inc.FST2026-04-30
00816835024452SYSTEM TWO LEDMedical Illumination International Inc.FST2026-04-30
00816835024469SYSTEM TWO LEDMedical Illumination International Inc.FST2026-04-30
00816835024476SYSTEM TWO LEDMedical Illumination International Inc.FST2026-04-30
00816835024483SYSTEM TWO LEDMedical Illumination International Inc.FST2026-04-30
10845854040379CONMEDConmed CorporationFST2026-03-24
00816744020118NICO MyriadNICO CORPORATIONFST2025-07-30
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00816744021337NICO MyriadNICO CORPORATIONFST2025-07-30
00816835024360Vu160Medical Illumination International Inc.FST2025-02-19
00816835024353Vu160Medical Illumination International Inc.FST2025-02-19
01816835024369Vu160Medical Illumination International Inc.FST2025-02-19
00816744020095NICO MyriadNICO CORPORATIONFST2024-11-13
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00816835024346SM1Medical Illumination International Inc.FST2024-09-04
01816835024345SM1Medical Illumination International Inc.FST2024-09-04
00816835024322MI-1000CAMMedical Illumination International Inc.FST2024-08-19
00816835024339MI-1000CAMMedical Illumination International Inc.FST2024-08-19
01816835024321MI-1000CAMMedical Illumination International Inc.FST2024-08-19
01816835024338MI-1000CAMMedical Illumination International Inc.FST2024-08-19
00840606184922Lucent LateralSPINAL ELEMENTS, INC.FST2024-08-13
00840606184946Lucent LateralSPINAL ELEMENTS, INC.FST2024-08-13
00816744027728NICO Myriad SPECTRANICO CORPORATIONFST2024-06-07