Identity
- Trade Name
- CentLoc Total Knee System FDA UDI
- Generic Name
- Femur/tibia shaft prosthesis FDA UDI
- Device Name
- CentLoc Tibial tray component Ti6Al4V Size8-1 FDA UDI
- Model / Reference
- 7122-5276 FDA UDI
- Description
- CentLoc Tibial tray component Ti6Al4V Size8-1 FDA UDI
Identifiers
- Catalog Number
- 7122-5276 FDA UDI
- Primary DI / UDI-DI
- 08800036800931 FDA UDI
- 510(k) Number
- K182370 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Femur/tibia shaft prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Femur/tibia shaft prosthesis
CentLoc Total Knee System by RootLoc Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Femur/tibia shaft prosthesis.
- MAXIM KNEE SYSTEM — Biomet Orthopedics, Inc. · Class II
- ORTHOPEDIC SALVAGE SYSTEM — Biomet Orthopedics, Inc. · Class II
- ACS® — implantcast GmbH · Class II
- ACS® — implantcast GmbH · Class II
- ORTHOPEDIC SALVAGE SYSTEM — Biomet Orthopedics, Inc. · Class II
- ACS® — implantcast GmbH · Class II
- CentLoc Total Knee System — RootLoc Co., Ltd. · Class II
- CentLoc Total Knee System — RootLoc Co., Ltd. · Class II
Cleared under the same submission
K182370 also covers:
- CentLoc Total Knee System — RootLoc Co., Ltd.
- CentLoc Total Knee System — RootLoc Co., Ltd.
- CentLoc Total Knee System — RootLoc Co., Ltd.
- CentLoc Total Knee System — RootLoc Co., Ltd.
- CentLoc Total Knee System — RootLoc Co., Ltd.
- CentLoc Total Knee System — RootLoc Co., Ltd.
- CentLoc Total Knee System — RootLoc Co., Ltd.
- CentLoc Total Knee System — RootLoc Co., Ltd.
- CentLoc Total Knee System — RootLoc Co., Ltd.
- CentLoc Total Knee System — RootLoc Co., Ltd.
- CentLoc Total Knee System — RootLoc Co., Ltd.
- CentLoc Total Knee System — RootLoc Co., 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 |
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Manufacturer
- Manufacturer
- RootLoc Co., Ltd.
Sources (1)
- FDA UDI 2ad83764-3ad5-426e-a11d-0eb8328dbd3c 35 fields · synced May 31, 2026