Identity
- Trade Name
- Legend Acetabular Shell FDA UDI
- Generic Name
- Acetabular shell FDA UDI
- Device Name
- No Hole, 64 mm FDA UDI
- Model / Reference
- 170-0464 FDA UDI
- Description
- No Hole, 64 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822409035359 FDA UDI
- 510(k) Number
- K161080 FDA UDI
- FDA Product Code
- LZO FDA UDILPH FDA UDI
- GMDN Term
- Acetabular shell FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3358 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 — 64 Millimeter FDA UDI
Category: Acetabular shell
Legend Acetabular Shell by Ortho Development Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K161080 also covers:
- Legend Acetabular Shell — ORTHO DEVELOPMENT CORP.
- Legend Acetabular Shell — ORTHO DEVELOPMENT CORP.
- Legend Acetabular Shell — ORTHO DEVELOPMENT CORP.
- Legend Acetabular Shell — ORTHO DEVELOPMENT CORP.
- Legend Acetabular Shell — ORTHO DEVELOPMENT CORP.
- Legend Acetabular Shell — ORTHO DEVELOPMENT CORP.
- Legend Acetabular Shell — ORTHO DEVELOPMENT CORP.
- Legend Acetabular Shell — ORTHO DEVELOPMENT CORP.
- Legend Acetabular Shell — ORTHO DEVELOPMENT CORP.
- Legend Acetabular Shell — ORTHO DEVELOPMENT CORP.
- Legend Acetabular Shell — ORTHO DEVELOPMENT CORP.
- Legend Acetabular Shell — ORTHO DEVELOPMENT CORP.
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
- Ortho Development Corp.
Sources (1)
- FDA UDI de5a2739-ceb3-4541-91c6-0195eb47cc18 36 fields · synced May 30, 2026