Identity
- Trade Name
- Staple All-in-One, 10mm, 26° EUDAMEDAPTUS FDA UDI
- Generic Name
- Orthopaedic bone staple, non-adjustable FDA UDI
- Device Name
- Staples (sterile) EUDAMEDStaple All-in-One, 10mm, 26° FDA UDI
- Model / Reference
- A-4090.04S EUDAMEDFDA UDI
- Description
- Staple All-in-One, 10mm, 26° FDA UDI
Identifiers
- Catalog Number
- A-4090.04S FDA UDI
- Primary DI / UDI-DI
- 07630037889397 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300378018PK EUDAMED
- 510(k) Number
- K191636 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
- 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic bone staple, non-adjustable
Aptus by Medartis Inc. — 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
- Elite — Synthes · Class II
- MotoBAND™ CP DynaForce® MTP — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Speed Arc — Synthes · Class II
- JAWS Nitinol Staple System — Paragon 28 · Class II
Cleared under the same submission
K191636 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medartis Inc.
Sources (2)
- FDA UDI 83ef47bc-5bfb-4d18-8aa2-60d0bdcd12de 35 fields · synced Jul 12, 2026
- EUDAMED 07b7e6be-fb6d-469b-b0be-822b9466b5b0 61 fields · synced Jul 12, 2026