FDA.reportPublic FDA data

Centrolock®

Primary DI
03700879511757
Brand
Centrolock®
Company
NOVASTEP
Model
XMS01030
Catalog number
XMS01030
Device description
impactor
Published
2020-01-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192356000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192356000Airlock Centrolock Osteosynthesis Implant SystemNovastep2019-12-14HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700879511757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700879511757037008795117573700879511757

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+33299338650contact@novastep-ortho.com
+33299338650regulatory-IntFA@enovis.com

Regulatory Flags#

DUNS number
264255288
Device count
1
Premarket 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
03700879515540airlock®XDB01027XDB010272026-07-10
03700879518701NAXMS01056XMS010562026-06-23
03700879518718NAXMS01057XMS010572026-06-23
03700879518725NAXMS01058-1XMS01058-12026-06-23
03700879518732NAXMS01058-2XMS01058-22026-06-23
03700879518565PECAPLASTY®ACC1025P0001ACC1025P00012026-03-19
03700879518572PECAPLASTY®ACC1025P0002ACC1025P00022026-03-19
03700879518589PECAPLASTY®XMS01055-1XMS01055-12026-03-19
03700879518596PECAPLASTY®XMS01055-2XMS01055-22026-03-19
03700879516479arcad® 2.0CSK101012CSK1010122024-08-08
03700879516486arcad® 2.0CSK121212CSK1212122024-04-16
03700879516493arcad® 2.0CSK151515CSK1515152024-04-16
03700879516509arcad® 2.0CSK181818CSK1818182024-04-16
03700879516516arcad® 2.0CSK202020CSK2020202024-04-16
03700879516523arcad® 2.0CSK252020CSK2520202024-04-16
03700879516530arcad® 2.0CSK261818CSK2618182024-04-16
03700879516547arcad® 2.0CSK302020CSK3020202024-04-16
03700879516554arcad® 2.0CSK301612CSK3016122024-04-16
03700879500386arcad®CS010909CS0109092015-10-16
03700879500393arcad®CS011214CS0112142015-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000675028n/aMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00824846002468Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00763000837198Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-18
08904255300064ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
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08904255300088ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300095ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300101ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300118ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300125ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300132ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300149ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300156ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300163ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300170ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300187ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300194ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300200ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300217ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300224ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300231ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300248ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300255ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300262ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300705ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300712ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300729ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300736ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300743ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300750ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18