Identity
- Trade Name
- MobileLink Acetabular Cup System FDA UDI
- Generic Name
- Metallic acetabular liner FDA UDI
- Device Name
- Dual Mobility Insert FDA UDI
- Model / Reference
- 183-930/01 FDA UDI
- Description
- Dual Mobility Insert FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04026575209446 FDA UDI
- 510(k) Number
- K200607 FDA UDI
- FDA Product Code
- OQG FDA UDILPH FDA UDI
- GMDN Term
- Metallic acetabular liner 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Metallic acetabular liner
MobileLink Acetabular Cup System by WALDEMAR LINK GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metallic acetabular liner.
- EMPHASYS — DEPUY (IRELAND) · Class II
- Micro Seal Shell — Signal Medical Corp. · Class II
- Micro Seal Shell — Signal Medical Corp. · Class II
- Logical Dual Mobility CoCr Liner — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- OR3O Dual Mobility — Smith & Nephew, Inc. · Class II
- EMPHASYS — DEPUY (IRELAND) · Class II
- Micro Seal Shell — Signal Medical Corp. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
Cleared under the same submission
K200607 also covers:
- MobileLink Acetabular Cup System — WALDEMAR LINK GmbH & Co. KG
- MobileLink Acetabular Cup System — WALDEMAR LINK GmbH & Co. KG
- MobileLink Acetabular Cup System — WALDEMAR LINK GmbH & Co. KG
- MobileLink Acetabular Cup System — WALDEMAR LINK GmbH & Co. KG
- MobileLink Acetabular Cup System — WALDEMAR LINK GmbH & Co. KG
- MobileLink Acetabular Cup System — WALDEMAR LINK GmbH & Co. KG
- MobileLink Acetabular Cup System — WALDEMAR LINK GmbH & Co. KG
- MobileLink Acetabular Cup System — WALDEMAR LINK GmbH & Co. KG
- MobileLink Acetabular Cup System — WALDEMAR LINK GmbH & Co. KG
- MobileLink Acetabular Cup System — WALDEMAR LINK GmbH & Co. KG
- MobileLink Acetabular Cup System — WALDEMAR LINK GmbH & Co. KG
- MobileLink Acetabular Cup System — WALDEMAR LINK GmbH & Co. KG
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
- WALDEMAR LINK GmbH & Co. KG
Sources (1)
- FDA UDI 5a935a83-b4a4-4c69-8a85-61b358d11ce0 34 fields · synced Jun 8, 2026