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Percusys® Plus Pedicle Screw monoaxial
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref JMPP0850MS
by Joimax GmbH
Identity
- Trade Name
- Percusys® Plus Pedicle Screw monoaxial EUDAMEDPercusys® Plus FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- Percusys® Plus Pedicle Screw monoaxial EUDAMEDFDA UDI
- Model / Reference
- JMPP0850MS EUDAMEDFDA UDI
- Description
- Percusys® Plus Pedicle Screw monoaxial FDA UDI
Identifiers
- Catalog Number
- JMPP0850MS FDA UDI
- Primary DI / UDI-DI
- 04250337106951 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337106951 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
- Spinal bone screw, non-bioabsorbable 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 Pedicle Screw monoaxial 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-04250337106951 | 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 9d1caae4-be39-4e57-aafb-fd2b9a46cf27 61 fields · synced Jun 20, 2026
- FDA UDI ff124ee0-9079-4201-be0f-61ba6f6f72c7 36 fields · synced May 29, 2026