Identity
- Trade Name
- Performa FDA UDI
- Generic Name
- Uncoated femoral stem prosthesis, modular FDA UDI
- Device Name
- Collarless Hip Stem for cemented applications - Size 1 (139 x 9mm) (12/14 Taper) FDA UDI
- Model / Reference
- Collarless Hip Stem - Size 1 (139 x 9mm) FDA UDI
- Description
- Collarless Hip Stem for cemented applications - Size 1 (139 x 9mm) (12/14 Taper) FDA UDI
Identifiers
- Catalog Number
- HS1361 FDA UDI
- Primary DI / UDI-DI
- 05051693300972 FDA UDI
- 510(k) Number
- K923898 FDA UDI
- FDA Product Code
- JDI FDA UDI
- GMDN Term
- Uncoated femoral stem prosthesis, modular FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3350 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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 139 Millimeter FDA UDI
Category: Uncoated femoral stem prosthesis, modular
Performa by Implants International Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated femoral stem prosthesis, modular.
- Profemur — MicroPort Orthopedics Inc. · Class III
- Perfecta — MicroPort Orthopedics Inc. · Class II
- GUARDIAN® — MicroPort Orthopedics Inc. · Class II
- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
- Perfecta — MicroPort Orthopedics Inc. · Class III
- GUARDIAN® — MicroPort Orthopedics Inc. · Class II
Cleared under the same submission
K923898 also covers:
- Performa — IMPLANTS INTERNATIONAL LTD
- Performa — IMPLANTS INTERNATIONAL LTD
- Performa — IMPLANTS INTERNATIONAL LTD
- Performa — IMPLANTS INTERNATIONAL LTD
- Performa — IMPLANTS INTERNATIONAL LTD
- Performa — IMPLANTS INTERNATIONAL LTD
- Performa — IMPLANTS INTERNATIONAL LTD
- Performa — IMPLANTS INTERNATIONAL LTD
- Performa — IMPLANTS INTERNATIONAL LTD
- Performa — IMPLANTS INTERNATIONAL LTD
- Performa — IMPLANTS INTERNATIONAL LTD
- Performa — IMPLANTS INTERNATIONAL LTD
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Implants International Ltd
Sources (1)
- FDA UDI 471b02cd-ca71-4150-a2b0-51e4690b00ac 38 fields · synced Jun 1, 2026