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Stratos
EUDAMEDFDA 510(k)FDA UDIClass IIb (EU MDR)
Ref 012-04226Ref 012-05110Ref 014-10192Ref 014-10195Ref 012-01451Ref 014-10191Ref 014-10193Ref 014-01004Ref 012-03451Ref 012-05011Ref 012-02451Ref 014-01002510(k) K073556Ref 015-01010Ref 015-01310Ref 015-01120Ref 012-04451Ref 015-01220Ref 012-02226
Identity
- Trade Name
- STRATOS EUDAMEDTitanium Sternum Double-clip M FDA UDITitanium Sternum Double-clip M/L FDA UDITitanium Sternum Single-clip S FDA UDITitanium Sternum Triple-clip S FDA UDI
- Generic Name
- Sternal fixation device FDA UDI
- Device Name
- 012-04226 Titan Rippenklammer, rechts, 22,5°, XL, rotierbarer Konnektor EUDAMED012-05110 Titan Rippenklammer, 2 Segmente, Standard, rotierbarer Konnektor EUDAMED014-10192 Titan Verbindungssteg, 20mm Gleitfunktion mit Stopp, 195mm EUDAMED014-10195 Titan Verbindungssteg, Gleitfunktion mit Stopp, 195mm EUDAMED012-01451 Titan Rippenklammer, links, 45°, Standard, rotierbarer Konnektor EUDAMED014-10191 Titan Verbindungssteg, 10mm Gleitfunktion mit Stopp, 195mm EUDAMED014-10193 Titan Verbindungssteg, 30mm Gleitfunktion mit Stopp, 195mm EUDAMED014-01004 Titan Rippenklammer, gerade, XL, rotierbarer Konnektor EUDAMED012-03451 Titan Rippenklammer, links, 45°, XL, rotierbarer Konnektor EUDAMED012-05011 Titan Rippenklammer, 2/1 Segmente, XL, rotierbarer Konnektor EUDAMED012-02451 Titan Rippenklammer, rechts, 45°, Standard, rotierbarer Konnektor EUDAMED014-01002 Titan Rippenklammer, gerade, Standard, rotierbarer Konnektor EUDAMED015-01010 Titan Sternum Einzel-Klammer S EUDAMED015-01310 Titan Sternum Tripel-Klammer S EUDAMED015-01120 Titan Sternum Doppel-Klammer M EUDAMED012-04451 Titan Rippenklammer, rechts, 45°, XL, rotierbarer Konnektor EUDAMED015-01220 Titan Sternum Doppel-Klammer M/L EUDAMED012-02226 Titan Rippenklammer, rechts, 22,5°, Standard, rotierbarer Konnektor EUDAMED
- Model / Reference
- 012-04226 EUDAMED012-05110 EUDAMED014-10192 EUDAMED014-10195 EUDAMED012-01451 EUDAMED014-10191 EUDAMED014-10193 EUDAMED014-01004 EUDAMED012-03451 EUDAMED012-05011 EUDAMED012-02451 EUDAMED014-01002 EUDAMED015-01120 EUDAMEDFDA UDI015-01220 EUDAMEDFDA UDI015-01010 EUDAMEDFDA UDI015-01310 EUDAMEDFDA UDI012-04451 EUDAMED012-02226 EUDAMED
Identifiers
- Catalog Number
- 015-01120 FDA UDI015-01220 FDA UDI015-01310 FDA UDI
- Primary DI / UDI-DI
- 04260029586152 EUDAMED04260029588507 EUDAMED04260029588811 EUDAMED04260029586282 EUDAMED04260029586053 EUDAMED04260029588804 EUDAMED04260029588828 EUDAMED04260029586220 EUDAMED04260029586138 EUDAMED04260029582642 EUDAMED04260029586091 EUDAMED04260029586206 EUDAMED04260029583076 EUDAMEDFDA UDI04260029583113 EUDAMEDFDA UDI04260029583021 EUDAMEDFDA UDI04260029583137 EUDAMEDFDA UDI04260029586176 EUDAMED04260029586077 EUDAMED
- Basic UDI-DI
- B-04260029586152 EUDAMEDB-04260029588507 EUDAMEDB-04260029588811 EUDAMEDB-04260029586282 EUDAMEDB-04260029586053 EUDAMEDB-04260029588804 EUDAMEDB-04260029588828 EUDAMEDB-04260029586220 EUDAMEDB-04260029586138 EUDAMEDB-04260029582642 EUDAMEDB-04260029586091 EUDAMEDB-04260029586206 EUDAMEDB-04260029583021 EUDAMEDB-04260029583137 EUDAMEDB-04260029583076 EUDAMEDB-04260029586176 EUDAMEDB-04260029583113 EUDAMEDB-04260029586077 EUDAMED
- 510(k) Number
- K073556 FDA 510(k)
- FDA Product Code
- HRS FDA 510(k)FDA UDI
- EMDN Code
- P09120299 OSTEOSYNTHESIS NAILS - OTHER EUDAMED
- GMDN Term
- Sternal fixation device FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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
Yes
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
Stratos by MedXpert GmbH — Class IIb — MDR, FDA_510K, MDD — listed in EUDAMED, FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04260029586152 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K073556 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-04260029586152 | Class IIb | Active |
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Manufacturer
- Manufacturer
- MedXpert GmbH
- EUDAMED SRN
- DE-MF-000005489
Sources (23)
- EUDAMED 186cb573-44f9-4622-b1f5-9ef297c06a6f 61 fields · synced Sep 18, 2026
- EUDAMED acf85acb-b135-4832-a5f8-27442793617f 61 fields · synced May 16, 2026
- EUDAMED 4a8a31c3-66ac-4fc7-9784-e58c2422e2a1 61 fields · synced May 16, 2026
- EUDAMED f5e67b21-15f9-4089-8fd4-75644c5c49cb 61 fields · synced May 17, 2026
- EUDAMED 2f10a953-0962-4a70-a556-930689cecca0 61 fields · synced May 17, 2026
- EUDAMED cf9c862a-209b-45c6-b33c-ff3d977e8f1e 61 fields · synced May 17, 2026
- EUDAMED 867fae39-bce0-447c-9a54-5623ed710d6a 61 fields · synced May 17, 2026
- EUDAMED b3048609-e13a-45ef-8e46-9876785313a4 61 fields · synced May 17, 2026
- EUDAMED 288cb1c3-7262-49f0-9701-28cad1631baf 61 fields · synced May 17, 2026
- EUDAMED 577a630f-19b5-45b2-a132-21b8612e63c7 61 fields · synced May 17, 2026
- EUDAMED 5a59de66-0c4f-4703-8de2-f442645ce464 61 fields · synced May 17, 2026
- EUDAMED d229084a-3077-463b-a5f1-69a6a57b5adc 61 fields · synced May 18, 2026
- FDA 510(k) K073556 24 fields · synced May 18, 2026
- FDA UDI cb170723-1cca-42be-9e25-1ca5ecf16a96 34 fields · synced May 25, 2026
- FDA UDI 2df7fc66-872d-40c6-8e19-18815eee538d 34 fields · synced May 27, 2026
- FDA UDI 8ad59c74-3053-44e7-b50d-6ab15003175b 33 fields · synced May 30, 2026
- FDA UDI f4a85f31-f19f-4e20-bb5e-5728c8c2a461 34 fields · synced May 30, 2026
- EUDAMED f06660dc-796a-41a4-8203-aad688d6f57d 61 fields · synced Jul 12, 2026
- EUDAMED 6cd342b5-3785-4e19-85c9-a6d802e646fc 61 fields · synced Jul 15, 2026
- EUDAMED ad97e6c7-f7eb-425d-b186-eca07189ed98 61 fields · synced Jul 16, 2026
- EUDAMED d30c657b-e13d-4423-bf70-655c5ee9189c 61 fields · synced Jul 20, 2026
- EUDAMED a1695b07-5123-4e45-a9df-f8f3fcda5535 61 fields · synced Jul 22, 2026
- EUDAMED 6726156d-8eb3-418e-b251-032b4902a93e 61 fields · synced Sep 18, 2026