FDA.reportPublic FDA data

lync®

Primary DI
03700879500898
Brand
lync®
Company
NOVASTEP
Model
XFP04001
Catalog number
XFP04001
Device description
forceps
Published
2016-09-15
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
HTYPin, Fixation, Smooth
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143049000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143049000LYNC intramedullary implantNovastep2015-02-19HTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700879500898PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700879500898037008795008983700879500898

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
03700879517803airlock®ACC1022P0002ACC1022P00022026-08-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986489425LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-08-19
08809986489432LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-08-19
M9432002230000Liberty SISpinal Simplicity, LLCLXH2026-08-19
00198506093937ELMED INCORPORATEDELMED INCORPORATEDLXH2026-08-18
00198506094194ELMED INCORPORATEDELMED INCORPORATEDLXH2026-08-18
00810130207534MSIModern Surgical Instruments LLCLXH2026-08-18
00810198920345General InstrumentsTheraMicro, LLCLXH2026-08-18
00810198920352TeKForceTheraMicro, LLCLXH2026-08-18
00810198920376TeKForceTheraMicro, LLCLXH2026-08-18
00850078396396ActivaScrew™ Cannulated COM Single-Use Accessory Kit 3.5/4.0/4.5 mm(1054)Eca Medical InstrumentsLXH2026-08-18
08053782781652Bioplan Instruments KitBRM EXTREMITIES SRLLXH2026-08-18
08057717553635BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553642BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553659BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553666BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553673BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553680BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553697BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553703BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553710BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553727BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553734BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553741BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553758BRM BIOPLAN INSTRUMENTSBRM EXTREMITIES SRLLXH2026-08-18
08800104097980Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.LXH2026-08-18
08800322750834PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.LXH2026-08-18
08800322758106PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.LXH2026-08-18
08800322758113PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.LXH2026-08-18
08800322759523QUASAR Standalone ACIF SystemGS Medical Co., Ltd.LXH2026-08-18
08800322759530QUASAR Standalone ACIF SystemGS Medical Co., Ltd.LXH2026-08-18