Percusys® Plus

Primary DI
04250337106531
Brand
Percusys® Plus
Company
Joimax GmbH
Model
JMPP0535PS
Catalog number
JMPP0535PS
Device description
Percusys® Plus Pedicle Screw polyaxial
Published
2020-01-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192680000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192680000Percusys® Plus Pedicle Screw SystemJoimax GmbH2019-12-18NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250337106531PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250337106531042503371065314250337106531

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Contacts#

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

Regulatory Flags#

DUNS number
344267187
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250337121015Combo Optic AdapterADAPTC12026-10-19
04250337118022Intracs®JINTST15JINTST152022-12-30
04250337118039Intracs®JINTST18JINTST182022-12-30
04250337118046Intracs®JINTST23JINTST232022-12-30
04250337116530Joimax® Intracs® EM System Integrated Navigation Tracking & Control SystemJINT01S2021-11-12
04250337116547Joimax® Intracs® EM Panel PCJINTPC11052021-11-12
04250337116554Joimax® Intracs® EM Control UnitJINTCU11152021-11-12
04250337116561Joimax® Intracs® EM Field GeneratorJINTFG11252021-11-12
04250337116585Joimax® Intracs® EM Patient TrackerJINTPT22352021-11-12
04250337116592Joimax® Intracs® EM Sensor ClipJINTSC22052021-11-12
04250337116608Joimax® Intracs® EM Sensor Wire 150JINTSW22152021-11-12
04250337116615Joimax® Intracs® EM Sensor Wire 180JINTSW22182021-11-12
04250337116622Joimax® Intracs® EM Sensor Wire 230JINTSW22232021-11-12
04250337116646Joimax® Intracs® EM Mounting Arm f field Generator mounting arm + rail clampJINTMA11352021-11-12
04250337117667Joimax® Intracs® EM Mounting Arm f. Patient Mapper mounting arm + rail clampJINTMAP11362021-11-12
04250337117988Wire cutterJINTWC2021-11-12
04250337117995Joimax® Intracs® EM Y-AdapterJINTYA352021-11-12
04250337118008Joimax® Intracs® EM K-Wire Drill Guide W 18 mm x D 28 mm x H 60 mmJINTDG1828602021-11-12
04250337118015K-Wire w/ thread, Trocar w. 15 mm thread, round 1.5 mm x 150 mmJKW15152021-11-12
04250337118213Joimax® Intracs® EM Patient Mapper - APJINTPM2245-AP2021-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157122515ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122522ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122539ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122546ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122553ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122560ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122577ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122584ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122591ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122607ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122614ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122621ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122638ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122645ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122652ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122669ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122676ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122683ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122690ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122706ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122713ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122720ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122737ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122744ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122751ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122768ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122775ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122782ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122799ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122805ZAVATION SCREWZavation LLCNKB2026-10-19