Identity
- Trade Name
- AO Spinner Blade EUDAMEDdeflector FDA UDI
- Generic Name
- Spinal shaver system blade FDA UDI
- Device Name
- AO Spinner Blade EUDAMEDAO Spinner Blade, 9 mm FDA UDI
- Model / Reference
- JSBSR15009 EUDAMEDFDA UDI
- Description
- AO Spinner Blade, 9 mm FDA UDI
Identifiers
- Catalog Number
- JSBSR15009 FDA UDI
- Primary DI / UDI-DI
- 04250337120797 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371SPINAOHK EUDAMED
- Direct Marketing DI
- 04250337120797 EUDAMED
- FDA Product Code
- HWE FDA UDI
- EMDN Code
- Z12130585 MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Spinal shaver system blade FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 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
No
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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Spinal shaver system blade
deflector by Joimax, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Spinal shaver system blade.
- Disposable Burs — Hicren (Zhejiang) Medtech Co., Ltd. · Class IIa
- Single-use Sterile Bur — Chongqing Xishan Science & Technology Co., Ltd. · Class IIa
- Single-use Sterile Bur — Chongqing Xishan Science & Technology Co., Ltd. · Class IIa
- Single-use Sterile Bur — Chongqing Xishan Science & Technology Co., Ltd. · Class IIa
- Disposable Burs — Hicren (Zhejiang) Medtech Co., Ltd. · Class IIa
- Disposable Burs — Hicren (Zhejiang) Medtech Co., Ltd. · Class IIa
- Single-use Sterile Bur — Chongqing Xishan Science & Technology Co., Ltd. · Class IIa
- Diamond Abrasor, Ball Tip, Coarse — Joimax GmbH · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Joimax, Inc.
Sources (2)
- FDA UDI f082f065-a68a-40c7-8890-65de482efcc0 34 fields · synced Aug 4, 2026
- EUDAMED 9ac6efa2-1ff1-4a41-b270-0b008f5b7bcf 61 fields · synced Aug 4, 2026