FDA.reportPublic FDA data

nuMIS Lumbar Plating System

Primary DI
00841193102443
Brand
nuMIS Lumbar Plating System
Company
Cutting Edge Spine, LLC
Model
27109-040
Catalog number
27109-040
Device description
8.5 x 40 mm Long Threaded, Ti Bolt
Published
2015-10-30
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
MNHOrthosis, spondylolisthesis spinal fixation
MNIORTHOSIS, SPINAL PEDICLE FIXATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051044000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051044000ARCTEC SEMIRIGID PLATING SYSTEMAltiva Corp.2005-10-07MNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841193102443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841193102443008411931024438411931024430841193102443

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length40Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(704)243-0892B.Roof@cuttingedgespine.com

Regulatory Flags#

DUNS number
069472647
Device count
1
DM exempt
true
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
00841193127996T-FIX™3Dsi Joint Fusion SystemCES-6432026-03-24
00841193127521EVOL®ha-Hyper C Cervical Interbody System6012-0507A6012-0507A2026-03-11
00841193127538EVOL®ha-Hyper C Cervical Interbody System6012-0607A6012-0607A2026-03-11
00841193127545EVOL®ha-Hyper C Cervical Interbody System6012-0707A6012-0707A2026-03-11
00841193127552EVOL®ha-Hyper C Cervical Interbody System6012-0807A6012-0807A2026-03-11
00841193127569EVOL®ha-Hyper C Cervical Interbody System6012-0907A6012-0907A2026-03-11
00841193127576EVOL®ha-Hyper C Cervical Interbody System6012-1007A6012-1007A2026-03-11
00841193127583EVOL®ha-Hyper C Cervical Interbody System6012-1107A6012-1107A2026-03-11
00841193127590EVOL®ha-Hyper C Cervical Interbody System6012-1207A6012-1207A2026-03-11
00841193127606EVOL®ha-Hyper C Cervical Interbody System6013-0512A6013-0512A2026-03-11
00841193127613EVOL®ha-Hyper C Cervical Interbody System6013-0612A6013-0612A2026-03-11
00841193127620EVOL®ha-Hyper C Cervical Interbody System6013-0712A6013-0712A2026-03-11
00841193127637EVOL®ha-Hyper C Cervical Interbody System6013-0812A6013-0712A2026-03-11
00841193127644EVOL®ha-Hyper C Cervical Interbody System6013-0912A6013-0912A2026-03-11
00841193127651EVOL®ha-Hyper C Cervical Interbody System6013-1012A6013-1012A2026-03-11
00841193127668EVOL®ha-Hyper C Cervical Interbody System6013-1112A6013-1112A2026-03-11
00841193127675EVOL®ha-Hyper C Cervical Interbody System6013-1212A6013-1212A2026-03-11
00841193101934EVOS Lumbar Interbody System4014-0164014-0162015-10-30
00841193104836EVOS Lumbar Interbody System4067-0104067-0102015-10-30
00841193105635EVOS Lumbar Interbody System4004-0144004-0142016-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840311244874Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311244874Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311244881Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311244881Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311244904Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311244904Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311244928Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311244928Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311244935Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311244935Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311244942Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311244942Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245017Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245017Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245024Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245024Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245062Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245062Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245079Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245079Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245130Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245130Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245154Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245154Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245161Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245161Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245185Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245185Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245208Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245208Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03