Identity
- Trade Name
- Conformis Hip System FDA UDI
- Generic Name
- Joint prosthesis implantation kit, single-use FDA UDI
- Device Name
- HIP-CORDERA TRIAL NECKS-SET OF 4 (29.0MM IN 127, 132DEG; 36.5MM IN 127, 132DEG) FDA UDI
- Model / Reference
- HAA050D00N01 FDA UDI
- Description
- HIP-CORDERA TRIAL NECKS-SET OF 4 (29.0MM IN 127, 132DEG; 36.5MM IN 127, 132DEG) FDA UDI
Identifiers
- Catalog Number
- HAA-050-D00N FDA UDI
- Primary DI / UDI-DI
- M572HAA050D00N011 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Joint prosthesis implantation kit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
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: Joint prosthesis implantation kit, single-use
Conformis Hip System by Conformis, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Joint prosthesis implantation kit, single-use.
- OvertureTi — OVERTURE ORTHOPAEDICS
- Dekalb Knee Pack — PACKROOM LLC
- Argo Knotless — Conmed Corporation · Class IIa
- Instruments IIa — Newclip Technics SAS · Class IIa
- CC-Hook Right — Xiros Limited · Class IIa
- Femoral Epimandrel — Episurf Operations AB · Class II
- Blunt pin — Si-Bone Inc. · Class IIa
- Y-KNOT — Conmed Corporation · Class IIa
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Conformis, Inc.
Sources (1)
- FDA UDI ea74a9f7-e602-4654-9eb5-bd9a4b3824bd 35 fields · synced Jun 8, 2026