FDA.reportPublic FDA data

Percusys®

Primary DI
04250337104384
Brand
Percusys®
Company
Joimax GmbH
Model
JMPS0835PS
Device description
Percusys® Pedicle Screw polyaxial OD 8 x 35 mm, incl. Set Screw
Published
2015-09-24
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
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143200000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143200000MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG2015-02-03NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250337104384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250337104384042503371043844250337104384

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of 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. Sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49721255140Quality@joimax.com

Regulatory Flags#

DUNS number
344267187
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250337117384video lensCSFHD01COVZCSFHD01COVZ2022-12-30
04260744830561Fibre optic cableCSLC0348CSLC03482022-12-30
04260744831865Fibre optic cableCSLC0252CSLC02522022-12-30
04250337119876Sterilisation trayJSBDSST4680JSBDSST46802022-12-30
04250337110040intENTS®TNC582810GTNC582810G2022-12-30
04250337110057MultiZYTE®TNC582814GTNC582814G2022-12-30
04250337110064iLESSYS®TNC582820RTNC582820R2022-12-30
04250337113041TESSYS®TNC582820TNC5828202022-12-30
04250337117537tubTNC5828100TNC58281002022-12-30
04250337117544tubTNC5828135TNC58281352022-12-30
04250337117551tubTNC5828150TNC58281502022-12-30
04250337117568tubTNC5828200TNC58282002022-12-30
04250337117575iLESSYS®TNC5828CLTNC5828CL2022-12-30
04250337117582iLESSYS®TNC5828ILTNC5828IL2022-12-30
04250337117599iLESSYS®TNC5828MLTNC5828ML2022-12-30
04250337117605iLESSYS®TNC5828NLTNC5828NL2022-12-30
04250337117612iLESSYS®TNC5828TLTNC5828TL2022-12-30
04250337117827iLESSYS®TNC5828ALTNC5828AL2022-12-30
04250337120759deflectorJSBS311509JSBS3115092025-07-25
04250337120766deflectorJSBS311512JSBS3115122025-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B678520297S0PressON™NEXUS SPINE, L.L.C.MNH2026-07-10
B678520297S0PressON™NEXUS SPINE, L.L.C.MNI2026-07-10
B678520297S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520298S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520298S0PressON™NEXUS SPINE, L.L.C.MNH2026-07-10
B678520298S0PressON™NEXUS SPINE, L.L.C.MNI2026-07-10
B678520299S0PressONNEXUS SPINE, L.L.C.MNI2026-07-10
B678520299S0PressONNEXUS SPINE, L.L.C.MNH2026-07-10
B678520299S0PressONNEXUS SPINE, L.L.C.NKB2026-07-10
B678520300S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520300S0PressON™NEXUS SPINE, L.L.C.MNH2026-07-10
B678520300S0PressON™NEXUS SPINE, L.L.C.MNI2026-07-10
B678520301S0PressONNEXUS SPINE, L.L.C.NKB2026-07-10
B678520301S0PressONNEXUS SPINE, L.L.C.MNH2026-07-10
B678520301S0PressONNEXUS SPINE, L.L.C.MNI2026-07-10
B678520302S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520302S0PressON™NEXUS SPINE, L.L.C.MNI2026-07-10
B678520302S0PressON™NEXUS SPINE, L.L.C.MNH2026-07-10
B678520303S0PressONNEXUS SPINE, L.L.C.NKB2026-07-10
B678520303S0PressONNEXUS SPINE, L.L.C.MNH2026-07-10
B678520303S0PressONNEXUS SPINE, L.L.C.MNI2026-07-10
B678520304S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520304S0PressON™NEXUS SPINE, L.L.C.MNH2026-07-10
B678520304S0PressON™NEXUS SPINE, L.L.C.MNI2026-07-10
B678520305S0PressONNEXUS SPINE, L.L.C.NKB2026-07-10
B678520305S0PressONNEXUS SPINE, L.L.C.MNH2026-07-10
B678520305S0PressONNEXUS SPINE, L.L.C.MNI2026-07-10
B678520306S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520306S0PressON™NEXUS SPINE, L.L.C.MNH2026-07-10
B678520306S0PressON™NEXUS SPINE, L.L.C.MNI2026-07-10