Identity
- Trade Name
- iTotal® Hip Replacement System FDA UDI
- Generic Name
- Polyethylene acetabulum prosthesis FDA UDI
- Device Name
- HIP-SCREW-6.5MM X 30MM FDA UDI
- Model / Reference
- HAA030063001 FDA UDI
- Description
- HIP-SCREW-6.5MM X 30MM FDA UDI
Identifiers
- Catalog Number
- HAA0300630 FDA UDI
- Primary DI / UDI-DI
- M572HAA0300630011 FDA UDI
- 510(k) Number
- K162719 FDA UDI
- FDA Product Code
- OQG FDA UDIMEH FDA UDILZO FDA UDILPH FDA UDI
- GMDN Term
- Polyethylene acetabulum prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI888.3353 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
Yes
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: Polyethylene acetabulum prosthesis
iTotal® Hip Replacement System by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyethylene acetabulum prosthesis.
- ZCA® — Zimmer, Inc. · Class II
- Acetabular Insert — Howmedica Osteonics Corp. · Class II
- Cenator Total Hip System — CORIN LTD · Class II
- Exeter — Howmedica Osteonics Corp. · Class II
- Exeter — Howmedica Osteonics Corp. · Class II
- ZCA® — Zimmer, Inc. · Class II
- REFLECTION — Smith & Nephew, Inc. · Class II
- ZCA® — Zimmer, Inc. · Class II
Cleared under the same submission
K162719 also covers:
- iTotal® Hip Replacement System — Conformis, Inc.
- iTotal® Hip Replacement System — Conformis, Inc.
- iTotal® Hip Replacement System — Conformis, Inc.
- iTotal® Hip Replacement System — Conformis, Inc.
- iTotal® Hip Replacement System — Conformis, Inc.
- iTotal® Hip Replacement System — Conformis, Inc.
- iTotal® Hip Replacement System — Conformis, Inc.
- iTotal® Hip Replacement System — Conformis, Inc.
- iTotal® Hip Replacement System — Conformis, Inc.
- iTotal® Hip Replacement System — Conformis, Inc.
- iTotal® Hip Replacement System — Conformis, Inc.
- iTotal® Hip Replacement System — Conformis, 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
- Conformis, Inc.
Sources (1)
- FDA UDI 8e1bff0d-35be-43b1-9d0a-72ffd71325a3 37 fields · synced Jun 6, 2026