Identity
- Trade Name
- ROSA® Recon FDA UDI
- Generic Name
- Robotic surgical arm system FDA UDI
- Device Name
- Platform FDA UDI
- Model / Reference
- 20-8020-110-01 FDA UDI
- Description
- Platform FDA UDI
Identifiers
- Catalog Number
- 20-8020-110-01 FDA UDI
- Primary DI / UDI-DI
- 00889024511170 FDA UDI
- 510(k) Number
- K182964 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Robotic surgical arm system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Robotic surgical arm system
ROSA® Recon by Orthosoft Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Robotic surgical arm system.
- daVinci Xi — Intuitive Surgical, Inc. · Class II
- SHURUI Large Tissue Forceps — Beijing Surgerii Robotics Company Limited · Class IIb
- FLEX — Medrobotics Corporation · Class II
- Flex — Medrobotics Corporation · Class II
- Adapter, Bipolar Large Grasping Forceps, Ø 5 mm x 310 mm — Asensus Surgical Italia S.r.l. · Class I
- FLEX — Medrobotics Corporation · Class II
- Senhance — Asensus Surgical, Inc. · Class II
- ARTAS System — Venus Concept Inc. · Class II
Cleared under the same submission
K182964 also covers:
- CLINICAL PC — Orthosoft Inc
- ROSA® — Orthosoft Inc
- ROSA® — Orthosoft Inc
- ROSA® KNEE SOFTWARE — Orthosoft Inc
- ROSA® KNEE SOFTWARE UPGRADE — Orthosoft Inc
- ROSA® Nexgen TKA cut guide - B — Orthosoft Inc
- ROSA® Nexgen TKA cut guide -A — Orthosoft Inc
- ROSA® Persona TKA cut guide - A — Orthosoft Inc
- ROSA® Persona TKA cut guide - B — Orthosoft Inc
- ROSA® Recon Platform — Orthosoft Inc
- ROSA® Vanguard TKA cut guide - A — Orthosoft Inc
- ROSA® Vanguard TKA cut guide - B — Orthosoft 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
- Orthosoft Inc
Sources (1)
- FDA UDI 906578b2-f322-476e-8faf-254a89fe8a48 36 fields · synced May 31, 2026