Identity
- Trade Name
- Encompass Hip Stem FDA UDI
- Generic Name
- Polymer orthopaedic cement restrictor, non-bioabsorbable FDA UDI
- Device Name
- 12mm Cement Restrictor FDA UDI
- Model / Reference
- 114-2012 FDA UDI
- Description
- 12mm Cement Restrictor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822409012961 FDA UDI
- 510(k) Number
- K962448 FDA UDI
- FDA Product Code
- KWY FDA UDI
- GMDN Term
- Polymer orthopaedic cement restrictor, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3390 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 — 12 Millimeter FDA UDI
Category: Polymer orthopaedic cement restrictor, non-bioabsorbable
Encompass Hip Stem by Ortho Development Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Polymer orthopaedic cement restrictor, non-bioabsorbable.
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- EXETER — Howmedica Osteonics Corp. · Class II
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Cleared under the same submission
K962448 also covers:
- Encompass Hip Stem — ORTHO DEVELOPMENT CORP.
- Encompass Hip Stem — ORTHO DEVELOPMENT CORP.
- Encompass Hip Stem — ORTHO DEVELOPMENT CORP.
- Encompass Hip Stem — ORTHO DEVELOPMENT CORP.
- Encompass Hip Stem — ORTHO DEVELOPMENT CORP.
- Encompass Hip Stem — ORTHO DEVELOPMENT CORP.
- Encompass Hip Stem — ORTHO DEVELOPMENT CORP.
- Encompass Hip Stem — ORTHO DEVELOPMENT CORP.
- Encompass Hip Stem — ORTHO DEVELOPMENT CORP.
- Encompass Hip Stem — ORTHO DEVELOPMENT CORP.
- Encompass Hip Stem — ORTHO DEVELOPMENT CORP.
- Encompass Hip Stem — 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 48ea0104-ba12-4a5c-b9b3-de2ff437ea08 36 fields · synced Jun 6, 2026