FDA.reportPublic FDA data

Percusys®

Primary DI
04250337104377
Brand
Percusys®
Company
Joimax GmbH
Model
JMPS0755PS
Device description
Percusys® Pedicle Screw polyaxial OD 7 x 55 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
04250337104377PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250337104377042503371043774250337104377

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
04250337117933Punching Adapter for Working TubeWTPA7695172026-10-22
04250337119180Guiding Tube, eccentrically cannulated, redGRD1964402026-10-22
04250337119197Guiding Tube, eccentrically cannulated, purpleGRD1774402026-10-22
04250337119203Working Tube with Handle, oblique 45°WTS1785032026-10-22
04250337119562Guiding Tube, conicalGTC1675962026-10-22
04250337119579Guiding rod , conicalGRD226320A.2026-10-22
04250337119586Guiding rod , conicalGRD226320B.2026-10-22
04250337119593Working Tube with crown half teeth tipWTS1780932026-10-22
04250337119647Working Tube with handle, Standard lipWTS2446592026-10-22
04250337119678Guiding rod, conical, longitudinal slantedGRD2042782026-10-22
04250337119791Working Tube with long lipWTS176050.2026-10-22
04250337120834Working tube, long lipWTDS1785752026-10-22
04250337121862Working Tube with Handle, Standard LipWTS1112002026-10-22
04250337121909Working Tube with Handle, Standard LipWTS111300T2026-10-22
04250337121916Working Tube with Handle, oblique 35°WTS1112032026-10-22
04250337121923Working Tube with Handle, oblique 35°WTS111303T2026-10-22
04250337121930Working Tube with Handle, long lipWTS1413022026-10-22
04250337122029Guiding Rod, conicalGRC1800102026-10-22
04250337122036Guiding Rod, conical, greenGRC2000392026-10-22
04250337121015Combo Optic AdapterADAPTC12026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840466901011PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
00840606174855PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
00840606175142PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
00840606175203PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
00840606185868PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
03701313009823KHEIRONS.M.A.I.ONKB2026-10-22
03701313009830KHEIRONS.M.A.I.ONKB2026-10-22
03701313009854KHEIRONS.M.A.I.ONKB2026-10-22
03701313009878KHEIRONS.M.A.I.ONKB2026-10-22
03701313009885KHEIRONS.M.A.I.ONKB2026-10-22
03701313009892KHEIRONS.M.A.I.ONKB2026-10-22
03701313009908KHEIRONS.M.A.I.ONKB2026-10-22
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00197157123628ZAVATION SCREWZavation LLCNKB2026-10-21
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00197157122874ZAVATION SCREWZavation LLCNKB2026-10-20
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00197157122898ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122904ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122911ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122928ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122935ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122942ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122959ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122966ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122973ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122980ZAVATION SCREWZavation LLCNKB2026-10-20