FDA.reportPublic FDA data

Percusys® Plus

Primary DI
04250337106661
Brand
Percusys® Plus
Company
Joimax GmbH
Model
JMPP0755PS
Catalog number
JMPP0755PS
Device description
Percusys® Plus Pedicle Screw polyaxial
Published
2020-01-03
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
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
04250337106661PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250337106661042503371066614250337106661

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
+49721255140customercare@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
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-06-28
10889981441555VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441609VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441616VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441623VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441661VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981065348MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065539MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065553MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065577MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065584MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065607MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065645MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065669MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065683MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065706MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065720MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065744MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065768MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065782MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065805MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065829MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065843MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065867MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065881MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065904MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065928MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065959MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065966MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065973MarinerSeaspine Orthopedics CorporationNKB2016-09-02