Identity
- Trade Name
- Cordera FDA UDI
- Generic Name
- Acetabulum prosthesis trial, prefabricated, single-use FDA UDI
- Device Name
- CORDERA LINER TRIAL GRP D range 54-57 36MM plus2 STD FDA UDI
- Model / Reference
- HDA-050-D22S-01 FDA UDI
- Description
- CORDERA LINER TRIAL GRP D range 54-57 36MM plus2 STD FDA UDI
Identifiers
- Catalog Number
- HDA-050-D22S FDA UDI
- Primary DI / UDI-DI
- M572HDA050D22S011 FDA UDI
- 510(k) Number
- K202484 FDA UDI
- FDA Product Code
- LPH FDA UDILZO FDA UDIMEH FDA UDIOQG FDA UDI
- GMDN Term
- Acetabulum prosthesis trial, prefabricated, single-use 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
No
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
Category: Acetabulum prosthesis trial, prefabricated, single-use
Cordera by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Acetabulum prosthesis trial, prefabricated, single-use.
- Hooded Acetabular Insert Trial — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- Hooded Acetabular Insert Trial — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- Klassic HD Acetabular Insert Trial — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- Klassic BiPolar Sizing Handle — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- Hooded Acetabular Insert Trial — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- Hooded Acetabular Insert Trial — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- Hooded Acetabular Insert Trial — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- Hooded Acetabular Insert Trial — TOTAL JOINT ORTHOPEDICS, INC. · Class I
Cleared under the same submission
K202484 also covers:
- Cordera — Conformis, Inc.
- Cordera — Conformis, Inc.
- Cordera — Conformis, Inc.
- Cordera — Conformis, Inc.
- Cordera — Conformis, Inc.
- Cordera — Conformis, Inc.
- Cordera — Conformis, Inc.
- Cordera Hip System (Stainless Steel) Trial Neck 127Degree, 36.5mm — Conformis, Inc.
- Cordera Hip System (Stainless Steel) Trial Neck 127degree, 29.0mm — Conformis, Inc.
- Cordera Hip System (Stainless Steel) Trial Neck 132deg, 36.5mm — Conformis, Inc.
- Cordera Hip System (Stainless Steel) Trial Neck 132degree, 29.0mm — Conformis, Inc.
- Cordera Hip System Radel Liner Impactors 28mm — 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 99dc61af-e841-4512-a85f-66648d208a06 36 fields · synced May 30, 2026