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Percusys® Plus Rod Ti-Alloy
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref JMPP0300RS
by Joimax GmbH
Identity
- Trade Name
- Percusys® Plus Rod Ti-Alloy EUDAMEDPercusys® Plus FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system rod FDA UDI
- Device Name
- Percusys® Plus Rod Ti-Alloy EUDAMEDFDA UDI
- Model / Reference
- JMPP0300RS EUDAMEDFDA UDI
- Description
- Percusys® Plus Rod Ti-Alloy FDA UDI
Identifiers
- Catalog Number
- JMPP0300RS FDA UDI
- Primary DI / UDI-DI
- 04250337107248 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337107248 EUDAMED
- 510(k) Number
- K192680 FDA UDI
- FDA Product Code
- NKB FDA UDI
- EMDN Code
- P090799 SPINAL PROSTHESES AND STABILISATION SYSTEMS - OTHER EUDAMED
- GMDN Term
- Bone-screw internal spinal fixation system rod FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Percusys® Plus Rod Ti-Alloy by Joimax GmbH — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04250337107248 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Joimax GmbH
- EUDAMED SRN
- DE-MF-000009201
Sources (2)
- EUDAMED e50ce8a9-c2bc-4e9b-b8da-970d9aa4e8ef 61 fields · synced Jul 16, 2026
- FDA UDI dc5ddc16-febe-4b04-8a26-12100226f94d 36 fields · synced May 30, 2026