FDA.reportPublic FDA data

PECAPLASTY®

Primary DI
03700879518596
Brand
PECAPLASTY®
Company
NOVASTEP
Model
XMS01055-2
Catalog number
XMS01055-2
Device description
Adjustable Offset
Published
2026-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700879518596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700879518596037008795185963700879518596

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
+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
03700879515687Airlock®XPP01006XPP010062026-08-25
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
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
00840606197472OMEGA XPSPINAL ELEMENTS, INC.LXH2026-10-29
00842078100219HammerFiXEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078100479IO FiXEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078100486XMCPEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078112410Axis BeamsEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078116197AlignXEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078123584KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124178Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124185Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124215Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129609KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129616KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129623KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129753IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129777IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129784IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129791IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
04250337122432iLESSYS® Interlaminar Endoscopic Surgical SystemJoimax GmbHLXH2026-10-29
07630699700689Knee InstrumentsMedacta International SALXH2026-10-29
08800017276182LOSPACorentec Co., LtdLXH2026-10-29
08806373878039LOSPACorentec Co., LtdLXH2026-10-29
08806373889653LOSPACorentec Co., LtdLXH2026-10-29
08806373894190LOSPACorentec Co., LtdLXH2026-10-29
10850070500101Core Wire, Removal Tool, ReusableCURVAFIX, INC.LXH2026-10-29
10855068008935Removal Tool Core Wire, DisposableCURVAFIX, INC.LXH2026-10-29
10888857615779K2M General InstrumentsVB Spine LLCLXH2026-10-28
M739193990906Non-Modular Convex TrialCAPTIVA SPINE, INC.LXH2026-10-28
M739193996906Non-Modular Lordotic Trial AssemblyCAPTIVA SPINE, INC.LXH2026-10-28
M739243999005SG Implant Driver-SCAPTIVA SPINE, INC.LXH2026-10-28
M739985202229Marking PinCAPTIVA SPINE, INC.LXH2026-10-28