Identity
- Trade Name
- 2.5/2.8 Concave Washer, 5/Pkg EUDAMEDAPTUS FDA UDI
- Generic Name
- Implantable bone washer FDA UDI
- Device Name
- Bone plates (sterile, non-sterile) EUDAMED2.5/2.8 Concave Washer, 5/Pkg FDA UDI
- Model / Reference
- A-4700.70 EUDAMEDFDA UDI
- Description
- 2.5/2.8 Concave Washer, 5/Pkg FDA UDI
Identifiers
- Catalog Number
- A-4700.70 FDA UDI
- Primary DI / UDI-DI
- 07630037863601 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300378020P6 EUDAMED
- Unit of Use DI
- 07630037804338 EUDAMED
- 510(k) Number
- K051567 FDA UDI
- FDA Product Code
- HRS FDA UDI
- EMDN Code
- P09120599 BONE FIXATION PLATES - OTHER EUDAMED
- GMDN Term
- Implantable bone washer FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Implantable bone washer
Aptus by Medartis Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Implantable bone washer.
- ISOLA — Depuy Spine, Inc. · Class II
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- Monster Screw System — Paragon 28 · Class II
- ALPHALOK Plating System — Vilex, Inc. · Class II
- Monster Screw System — Paragon 28 · Class II
- FLAT WASHER — Biomet Orthopedics, Inc. · Class II
- Fixcet Spinal Facet Screw System — Xtant Medical Holdings, Inc. · U
- LEOS Cannulated Screw System — Tyber Medical · Class II
Cleared under the same submission
K051567 also covers:
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medartis Inc.
Sources (2)
- FDA UDI dd674fa2-bfbf-427c-a432-6302386b573e 35 fields · synced Jun 18, 2026
- EUDAMED c573b0ba-ae64-4b05-940e-9bf67e0e125f 61 fields · synced Jun 18, 2026