← Back to catalogue
Bone Fixator "1-Pin", X-Press Size-L
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 52423B
by Brainlab SE
Identity
- Trade Name
- Bone Fixator "1-Pin", X-Press Size-L EUDAMEDBone Fixator 1-Pin, X-Press Size-L FDA UDI
- Generic Name
- Robotic surgical navigation system FDA UDI
- Device Name
- Spine & Trauma 3D Instruments EUDAMED
- Model / Reference
- 52423B EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 52423B FDA UDI
- Primary DI / UDI-DI
- 04056481002343 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04056481002343 EUDAMED
- FDA Product Code
- HAW FDA UDIOLO FDA UDI
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Robotic surgical navigation system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Neurological stereotactic surgery system
Bone Fixator "1-Pin", X-Press Size-L by Brainlab SE — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neurological stereotactic surgery system.
- PEEK INSTRUMENT ADAPTOR Ø2.15MM — MEDTECH LLC · Class II
- Mini-Bolt VUE Accessory Kit — MONTERIS MEDICAL CORP · Class I
- StealthAiR™ Spine — MEDTRONIC NAVIGATION, INC. · Class II
- StealthStation — MEDTRONIC NAVIGATION, INC. · Class II
- OsteoMed™ Manual Driver Handle — FHC, INC. · Class II
- PMT CORPORATION - STEREOTACTIC — Pmt Corp. · Class II
- Leksell Stereotactic System — Elekta Instrument AB · Class II
- Leksell Stereotactic System — Elekta Instrument AB · Class II
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-04056481002343 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (2)
- EUDAMED 0bc6ab2d-6212-4cfa-a81a-f9488b5fe54a 61 fields · synced Jul 10, 2026
- FDA UDI d623ca55-048b-43d7-bcc5-928580cf29d5 34 fields · synced May 30, 2026