← Back to catalogue
Triathlon AS-1 PS Box Ream CS Insert Cementless Instrumentation Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Triathlon AS-1 PS Box Ream CS Insert Cementless Instrumentation Kit FDA UDI
- Generic Name
- Total knee prosthesis implantation guide-instrument kit FDA UDI
- Device Name
- Triathlon AS-1 PS Surgical Instruments, CS insert, cementless, box ream, sizes 0-8 Right and Left FDA UDI
- Model / Reference
- 6556C01001 FDA UDI
- Description
- Triathlon AS-1 PS Surgical Instruments, CS insert, cementless, box ream, sizes 0-8 Right and Left FDA UDI
Identifiers
- Catalog Number
- 6556-C-010 FDA UDI
- Primary DI / UDI-DI
- M5726556C010011 FDA UDI
- 510(k) Number
- K203421 FDA UDI
- FDA Product Code
- OOG FDA UDIJWH FDA UDI
- GMDN Term
- Total knee prosthesis implantation guide-instrument kit 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Total knee prosthesis implantation guide-instrument kit
Triathlon AS-1 PS Box Ream CS Insert Cementless Instrumentation Kit by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total knee prosthesis implantation guide-instrument kit.
- PointCloud Knee Instruments — UNIK ORTHOPEDICS, INC · Class II
- PointCloud Knee Instruments — UNIK ORTHOPEDICS, INC · Class II
- PointCloud Knee Instruments — UNIK ORTHOPEDICS, INC · Class II
- PointCloud Knee Instruments — UNIK ORTHOPEDICS, INC · Class II
- PointCloud Knee Instruments — UNIK ORTHOPEDICS, INC · Class II
- AVID TruCustom — AVID MEDICAL, INC. · Class II
- PointCloud Knee Instruments — UNIK ORTHOPEDICS, INC · Class II
- PointCloud Knee Instruments — UNIK ORTHOPEDICS, INC · Class II
Cleared under the same submission
K203421 also covers:
- Triathlon AS-1 CR CS Insert Cemented Instrumentation Kit — Conformis, Inc.
- Triathlon AS-1 CR CS Insert Cementless Instrumentation Kit — Conformis, Inc.
- Triathlon AS-1 CR Cemented Instrumentation Kit — Conformis, Inc.
- Triathlon AS-1 CR Cementless Instrumentation Kit — Conformis, Inc.
- Triathlon AS-1 PS Box Chisel CS Insert Cemented Instrumentation Kit — Conformis, Inc.
- Triathlon AS-1 PS Box Chisel CS insert Cementless Instrumentation Kit — Conformis, Inc.
- Triathlon AS-1 PS Box Chisel Cemented Instrumentation Kit — Conformis, Inc.
- Triathlon AS-1 PS Box Chisel Cementless Instrumentation Kit — Conformis, Inc.
- Triathlon AS-1 PS Box Ream Cemented Instrumentation Kit — Conformis, Inc.
- Triathlon AS-1 PS Box Ream Cementless Instrumentation Kit — Conformis, Inc.
- Triathlon AS-1 PS Ream CS Insert Cemented Instrumentation Kit — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Conformis, Inc.
Sources (1)
- FDA UDI a6f96428-bd74-4f2f-aff5-6207ce092a81 37 fields · synced Jun 6, 2026