Identity
- Trade Name
- Continuum® Trabecular Metal™ FDA UDI
- Generic Name
- Acetabular shell FDA UDI
- Model / Reference
- 00-8757-070-01 FDA UDI
Identifiers
- Catalog Number
- 00-8757-070-01 FDA UDI
- Primary DI / UDI-DI
- 00889024151642 FDA UDI
- FDA Product Code
- LPH FDA UDILZO FDA UDIJDI FDA UDI
- GMDN Term
- Acetabular shell FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI888.3353 FDA UDI888.3350 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 — 70 Millimeter FDA UDI
Category: Acetabular shell
Continuum® Trabecular Metal™ by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K091508 also covers:
- Continuum® — Zimmer, Inc.
- Continuum® — Zimmer, Inc.
- Continuum® Trabecular Metal™ — Zimmer, Inc.
- Continuum® Trabecular Metal™ — Zimmer, Inc.
- Continuum® Trabecular Metal™ — Zimmer, Inc.
- Continuum® Trabecular Metal™ — Zimmer, Inc.
- Continuum® Trabecular Metal™ — Zimmer, Inc.
- Continuum® Trabecular Metal™ — Zimmer, Inc.
- Continuum® Trabecular Metal™ — Zimmer, Inc.
- Continuum® Trabecular Metal™ — Zimmer, Inc.
- Continuum® Trabecular Metal™ — Zimmer, Inc.
- Continuum® Trabecular Metal™ — Zimmer, Inc.
K151448 also covers:
- Continuum® Trabecular Metal™ — Zimmer, Inc.
- Continuum® Trabecular Metal™ — Zimmer, Inc.
- Continuum® Trabecular Metal™ — Zimmer, Inc.
- Continuum® Trabecular Metal™ — Zimmer, Inc.
- Continuum® Trabecular Metal™ — Zimmer, Inc.
- Continuum® Trabecular Metal™ — Zimmer, Inc.
- Continuum® Trabecular Metal™ — Zimmer, Inc.
- Continuum® Trabecular Metal™ — Zimmer, Inc.
- Continuum® Trabecular Metal™ — Zimmer, Inc.
- Continuum® Trabecular Metal™ — Zimmer, Inc.
- Continuum® Trabecular Metal™ — Zimmer, Inc.
- Continuum® Trabecular Metal™ — Zimmer, Inc.
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
- Zimmer, Inc.
Sources (1)
- FDA UDI 00d7edb2-7c88-49e0-ad35-43adc1467852 36 fields · synced May 30, 2026