Single-use OsteoSinter® COTTON instrument kit
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Single-use OsteoSinter® COTTON instrument kit FDA UDI
- Generic Name
- Surgical implant/trial-implant/sizer holder, single-use FDA UDI
- Device Name
- Single-use OsteoSinter® COTTON instrument kit EUDAMED
- Model / Reference
- P00413B1 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08437019951450 EUDAMEDFDA UDI
- Basic UDI-DI
- 8437019951p00100ckQ9 EUDAMED
- 510(k) Number
- K240461 FDA UDI
- FDA Product Code
- PLF FDA UDI
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Surgical implant/trial-implant/sizer holder, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
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
Yes
Manufacturing Date
Yes
Category: Surgical implant/trial-implant/sizer holder, single-use
Single-use OsteoSinter® COTTON 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
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
- Ames Medical Prosthetic Solutions S.a.
Sources (2)
- FDA UDI a037aef1-3d99-4381-bb28-9fd1068bdde3 34 fields · synced Oct 6, 2026
- EUDAMED a1aaaf8e-51fb-4c93-aac8-4cb3fe32ff1b 61 fields · synced Jul 20, 2026