← Back to catalogue
Omni Stable AF
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 155-14100Ref 144-35050Ref 155-40056
Identity
- Trade Name
- Omni Stable AF EUDAMEDFDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDIOrthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- Non-Locking Screw - 3.5 x 50mm EUDAMEDFDA UDISolid Screw, Non-Locking, 4.0 x 56mm EUDAMEDFDA UDIOmni Stable AF Straight Plate, 10 Holes EUDAMEDNon-Locking Screw - 3.5 x 42mm FDA UDIStraight Plate, 10 Holes FDA UDI
- Model / Reference
- 144-35050 EUDAMEDFDA UDI155-14100 EUDAMEDFDA UDI155-40056 EUDAMEDFDA UDI144-35042 FDA UDI
- Description
- Non-Locking Screw - 3.5 x 42mm FDA UDINon-Locking Screw - 3.5 x 50mm FDA UDIStraight Plate, 10 Holes FDA UDISolid Screw, Non-Locking, 4.0 x 56mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842078123485 EUDAMEDFDA UDI00842078122662 EUDAMEDFDA UDI00842078126202 EUDAMEDFDA UDI00842078123744 FDA UDI
- Basic UDI-DI
- B-00842078122662 EUDAMEDB-00842078123485 EUDAMEDB-00842078126202 EUDAMED
- 510(k) Number
- K212297 FDA UDI
- FDA Product Code
- HWC FDA UDIHRS FDA UDI
- EMDN Code
- P09120503 OSTEOSYNTHESIS SCREW-PLATE SYSTEMS EUDAMEDP09120601 CORTICAL SCREWS EUDAMED
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDIOrthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.3030 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile
Omni Stable AF by Extremity Medical, LLC — Class II — MDD, 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
- APTUS — Medartis 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
Cleared under the same submission
K212297 also covers:
- Omni Stable AF — Extremity Medical, LLC
- Omni Stable AF — Extremity Medical, LLC
- Omni Stable AF — Extremity Medical, LLC
- Omni Stable AF — Extremity Medical, LLC
- Omni Stable AF — Extremity Medical, LLC
- Omni Stable AF — Extremity Medical, LLC
- Omni Stable AF — Extremity Medical, LLC
- Omni Stable AF — Extremity Medical, LLC
- Omni Stable AF — Extremity Medical, LLC
- Omni Stable AF — Extremity Medical, LLC
- Omni Stable AF — Extremity Medical, LLC
- Omni Stable AF — Extremity Medical, LLC
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | 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
- Extremity Medical, LLC
Sources (7)
- FDA UDI ad09118d-e98f-417c-b130-6132c9d52c98 34 fields · synced Sep 30, 2026
- FDA UDI 492ebad8-13cc-4eb2-a144-af06ca92e3b2 34 fields · synced May 30, 2026
- FDA UDI 52f58d7a-c8ba-4680-9e48-bb70dc56eecc 34 fields · synced May 30, 2026
- FDA UDI 5a2a1331-98ef-49a5-9e13-425447d6b1d0 34 fields · synced May 30, 2026
- EUDAMED 8dcbdb7a-4541-436f-a0e8-3c8cd886bee0 61 fields · synced Sep 17, 2026
- EUDAMED 39fbef55-2586-42ed-b1e3-18df5cc2be87 61 fields · synced Sep 30, 2026
- EUDAMED d837a34c-5dcc-4db5-9247-b8878732f09e 61 fields · synced Sep 30, 2026