Identity
- Trade Name
- PROCOTYL FDA UDI
- Generic Name
- Metallic acetabulum prosthesis FDA UDI
- Model / Reference
- PHA06220 FDA UDI
Identifiers
- Catalog Number
- PHA06220 FDA UDI
- Primary DI / UDI-DI
- M684PHA062201 FDA UDI
- 510(k) Number
- K142119 FDA UDI
- FDA Product Code
- LZO FDA UDILPH FDA UDI
- GMDN Term
- Metallic acetabulum prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3358 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
Yes
FDA UDI
Category: Metallic acetabulum prosthesis
Procotyl by MicroPort Orthopedics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metallic acetabulum prosthesis.
- TRABECULAR METAL™ — Zimmer Trabecular Metal Technology, Inc. · Class II
- Platform Acetabular Cup with Ti-Coat — TOTAL JOINT ORTHOPEDICS, INC. · Class II
- b-ONE™ Primary Acetabular System — b-ONE Ortho Corp. · Class II
- Contour — Smith & Nephew, Inc. · Class II
- REGENEREX HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- DELTA TT Pro — Limacorporate · Class II
- Mpact 3D Metal — Medacta International · Class II
- BENCOX Hip System — Corentec Co., Ltd · Class II
Cleared under the same submission
K142119 also covers:
- PROCOTYL — MicroPort Orthopedics Inc.
- PROCOTYL — MicroPort Orthopedics Inc.
- PROCOTYL — MicroPort Orthopedics Inc.
- PROCOTYL — MicroPort Orthopedics Inc.
- PROCOTYL — MicroPort Orthopedics Inc.
- PROCOTYL — MicroPort Orthopedics Inc.
- PROCOTYL — MicroPort Orthopedics Inc.
- PROCOTYL — MicroPort Orthopedics Inc.
- PROCOTYL — MicroPort Orthopedics Inc.
- PROCOTYL — MicroPort Orthopedics Inc.
- PROCOTYL — MicroPort Orthopedics Inc.
- PROCOTYL — MicroPort Orthopedics 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
- MicroPort Orthopedics Inc.
Sources (1)
- FDA UDI 38d742a0-d32d-4444-83ba-727c4ce448f4 35 fields · synced Jun 9, 2026