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Single-use OsteoSinter® EVANS instrument kit
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Single-use OsteoSinter® EVANS instrument kit FDA UDI
- Generic Name
- Surgical implant/trial-implant/sizer holder, single-use FDA UDI
- Model / Reference
- P00401B1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08437019951443 FDA UDI
- 510(k) Number
- K240461 FDA UDI
- FDA Product Code
- PLF FDA UDI
- GMDN Term
- Surgical implant/trial-implant/sizer holder, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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: Surgical implant/trial-implant/sizer holder, single-use
Single-use OsteoSinter® EVANS instrument kit by Ames Medical Prosthetic Solutions S.a. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as Surgical implant/trial-implant/sizer holder, single-use.
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Cleared under the same submission
K240461 also covers:
- OsteoSinter® COTTON wedge 15L x 4.5H mm — AMES MEDICAL PROSTHETIC SOLUTIONS S.A.
- OsteoSinter® COTTON wedge 15L x 5.5H mm — AMES MEDICAL PROSTHETIC SOLUTIONS S.A.
- OsteoSinter® COTTON wedge 15L x 6.5H mm — AMES MEDICAL PROSTHETIC SOLUTIONS S.A.
- OsteoSinter® COTTON wedge 20L x 4.5H mm — AMES MEDICAL PROSTHETIC SOLUTIONS S.A.
- OsteoSinter® COTTON wedge 20L x 5.5H mm — AMES MEDICAL PROSTHETIC SOLUTIONS S.A.
- OsteoSinter® COTTON wedge 20L x 6.5H mm — AMES MEDICAL PROSTHETIC SOLUTIONS S.A.
- OsteoSinter® EVANS wedge 18W x 18L x 10H mm — AMES MEDICAL PROSTHETIC SOLUTIONS S.A.
- OsteoSinter® EVANS wedge 18W x 18L x 12H mm — AMES MEDICAL PROSTHETIC SOLUTIONS S.A.
- OsteoSinter® EVANS wedge 18W x 18L x 6H — AMES MEDICAL PROSTHETIC SOLUTIONS S.A.
- OsteoSinter® EVANS wedge 18W x 18L x 8H mm — AMES MEDICAL PROSTHETIC SOLUTIONS S.A.
- OsteoSinter® EVANS wedge 20W x 20L x 10H mm — AMES MEDICAL PROSTHETIC SOLUTIONS S.A.
- OsteoSinter® EVANS wedge 20W x 20L x 12H mm — AMES MEDICAL PROSTHETIC SOLUTIONS S.A.
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
- Ames Medical Prosthetic Solutions S.a.
Sources (2)
- FDA UDI 22d2fbc2-e755-4401-a019-6470b608d325 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026