Elite
FDA UDIEUDAMEDClass II (US FDA UDI)
by Synthes
Identity
- Trade Name
- BME ELITE EUDAMEDElite FDA UDI
- Generic Name
- Orthopaedic bone staple, non-adjustable FDA UDI
- Device Name
- BME ELITE, BME ELITE Y, BME SPEED, SPEEDTITAN, SPEEDARC, SPEEDTRIAD, SPEEDSHIFT Implant Kits EUDAMEDBME ELITE(TM) IMPLANT KIT 20 X 15 MM, 2 LEGS FDA UDI
- Model / Reference
- EL-2015S2 EUDAMEDFDA UDIBME ELITE, BME ELITE Y, BME SPEED, SPEEDTITAN, SPEEDARC, SPEEDTRIAD, SPEEDSHIFT Implant Kits EUDAMED
- Description
- BME ELITE(TM) IMPLANT KIT 20 X 15 MM, 2 LEGS FDA UDI
Identifiers
- Catalog Number
- EL2015S2 FDA UDI
- Primary DI / UDI-DI
- 07612334226662 EUDAMEDFDA UDI
- Basic UDI-DI
- 7611819a00645K4 EUDAMED
- 510(k) Number
- K150125 FDA UDI
- FDA Product Code
- JDR FDA UDI
- EMDN Code
- P09120101 OSTEOSYNTHESIS STAPLES EUDAMED
- GMDN Term
- Orthopaedic bone staple, non-adjustable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Orthopaedic bone staple, non-adjustable
Elite by Synthes — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone staple, non-adjustable.
- MotoCLIP/HiMAX Step Staple — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
- Step Boss — Biomedical Enterprises, Inc. · Class II
- Speed — Biomedical Enterprises, Inc. · Class II
- MotoBAND™ CP DynaForce® MTP — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
- Arthrex® — Arthrex, Inc. · Class II
- JAWS Nitinol Staple System — Paragon 28 · Class II
- GEO Staple System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC. · Class II
- CARINA — HNM TOTAL RECON LLC · Class II
Cleared under the same submission
K150125 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Synthes
Sources (2)
- FDA UDI 5961e5b9-db56-4c87-ba65-cfe6b914a9fe 36 fields · synced Jun 18, 2026
- EUDAMED 90d2be9c-69d7-4525-97af-c1d42d5e7277 61 fields · synced Jun 18, 2026