Identity
- Trade Name
- 2.2 headedCCS Long Thread, 29/10mm,1/Pkg EUDAMEDAPTUS FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- CCS EUDAMED2.2 headedCCS Long Thread, 29/10mm,1/Pkg FDA UDI
- Model / Reference
- A-5786.29/1 EUDAMEDFDA UDI
- Description
- 2.2 headedCCS Long Thread, 29/10mm,1/Pkg FDA UDI
Identifiers
- Catalog Number
- A-5786.29/1 FDA UDI
- Primary DI / UDI-DI
- 07630037867883 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300378019PM EUDAMED
- 510(k) Number
- K202589 FDA UDI
- FDA Product Code
- HWC FDA UDI
- EMDN Code
- P09120603 CANNULATED SCREWS EUDAMED
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
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
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile
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 screw, non-bioabsorbable, non-sterile.
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- Monster Screw System — Paragon 28 · Class II
- AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 75mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- SMOOTH PEG — Biomet Orthopedics, Inc. · Class II
- AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 105mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- QWIX — Newdeal Sas · Class II
- Monster Screw System — Paragon 28 · Class II
- TMS SYSTEM — BIOMET MICROFIXATION, INC · Class II
Cleared under the same submission
K202589 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
- Medartis Inc.
Sources (2)
- FDA UDI 88c0f9e5-05de-4cd1-b908-190d5207f1b6 35 fields · synced Jun 18, 2026
- EUDAMED 61b392f7-0853-4a92-b71b-fbffb824d131 61 fields · synced Jun 18, 2026