Identity
- Trade Name
- Iconacy i-Hip FDA UDI
- Generic Name
- Acetabular shell FDA UDI
- Device Name
- RS ACETABULAR CUP, 2-HOLE, 52M O.D. FDA UDI
- Model / Reference
- 01-10101-052-00 FDA UDI
- Description
- RS ACETABULAR CUP, 2-HOLE, 52M O.D. FDA UDI
Identifiers
- Catalog Number
- 01-10101-052-00 FDA UDI
- Primary DI / UDI-DI
- M914011010105200 FDA UDI
- 510(k) Number
- K131279 FDA UDI
- FDA Product Code
- LPH FDA UDI
- GMDN Term
- Acetabular shell FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 52 Millimeter FDA UDI
Category: Acetabular shell
Iconacy i-Hip by Iconacy Orthopedic Implants, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K131279 also covers:
- Iconacy i-Hip — Iconacy Orthopedic Implants, LLC
- Iconacy i-Hip — Iconacy Orthopedic Implants, LLC
- Iconacy i-Hip — Iconacy Orthopedic Implants, LLC
- Iconacy i-Hip — Iconacy Orthopedic Implants, LLC
- Iconacy i-Hip — Iconacy Orthopedic Implants, LLC
- Iconacy i-Hip — Iconacy Orthopedic Implants, LLC
- Iconacy i-Hip — Iconacy Orthopedic Implants, LLC
- Iconacy i-Hip — Iconacy Orthopedic Implants, LLC
- Iconacy i-Hip — Iconacy Orthopedic Implants, LLC
- Iconacy i-Hip — Iconacy Orthopedic Implants, LLC
- Iconacy i-Hip — Iconacy Orthopedic Implants, LLC
- Iconacy i-Hip — Iconacy Orthopedic Implants, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Iconacy Orthopedic Implants, LLC
Sources (1)
- FDA UDI c2b12466-4bb3-44b3-921f-c2aee882b982 37 fields · synced Jun 8, 2026