FDA.reportPublic FDA data

Robotic surgical navigation system application software

Definition
An individual application software program or group of programs, routines and/or algorithms designed for use in association with a robotic surgical navigation system used in computer assisted surgery (CAS) so that this can function according to its intended purpose. This program can be permanently installed or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.
GUDID devices
166
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00841690194699OMNIBoticsOmni Life Science, Inc.2205-20002023-01-10
00889024687455Rosa Knee SoftwareOrthosoft Inc20-8020-130-012025-11-21
07613327631814RPSStryker Leibinger GmbH & Co. KG88008000002025-10-03
037013115004453DSRW SoftwareECENTIAL ROBOTICSL000162023-03-01
07613327627725MakoMAKO SURGICAL CORP.Shoulder 1.0+TKA 2.0.1+TKA 1.0.3+THA 4.12026-03-10
07613327683653Shoulder 1.5 Installation DiskMAKO SURGICAL CORP.7000043787462026-03-03
00889024703186ROSA® ShoulderOrthosoft Inc20-8087-700-002026-01-27
00810180351003ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITED2.5.12025-11-17
00810180351027ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITED3.3.12025-11-17
00810180351065ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITED2.0.22025-11-17
B432360CAS3110360CASKICO KNEE INNOVATION COMPANY PTY LIMITED3.1.12025-07-17
03701311501497Op.n ChoiceSpine AppECENTIAL ROBOTICSL600182025-05-15
B432360CAS3100360CASKICO KNEE INNOVATION COMPANY PTY LIMITED3.1.02025-03-24
03701311501480Op.n Perla TL Nav SoftwareECENTIAL ROBOTICSL600172025-03-20
07613252196259FLUOROMAPStryker Leibinger GmbH & Co. KG81-810222025-01-28
07613252286578FLUOROMAPStryker Leibinger GmbH & Co. KG6006-600-0002025-01-28
07613252286622FLUOROMAPStryker Leibinger GmbH & Co. KG6006-600-3002025-01-28
04046963181901AESCULAPAesculap AGFS2172016-09-23
B432360CAS01450360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDKIC-DND-01452024-09-26
B432360CAS01470360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDKIC-DND-01472024-09-26
B432360CAS2200360CASKICO KNEE INNOVATION COMPANY PTY LIMITED2.2.02024-09-26
B432360CASSET00230360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDKIC-SET-00232024-09-26
B432360CASSET00280360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDKIC-SET-00282024-09-26
B432360CASSET00290360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDKIC-SET-00292024-09-26
00887868558306ROSA® ShoulderOrthosoft Inc20-8087-700-002024-03-06
B432360CAS01260360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDKIC-DND-01262024-01-11
B432360CAS01420360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDKIC-DND-01422024-01-11
B432360CASSET00220360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDKIC-SET-00222024-01-11
B432360CAS00040360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDKIC-DND-00042023-10-20
B432360CAS00250360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDKIC-DND-00252023-10-20
B432360CAS00260360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDKIC-DND-00262023-10-20
B432360CAS00280360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDKIC-DND-00282023-10-20
B432360CAS00750360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDKIC-DND-00752023-10-20
B432360CAS01020360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDKIC-DND-01022023-10-20
B432360CAS01030360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDKIC-DND-01032023-10-20
B432360CAS01050360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDKIC-DND-01052023-10-20
B432360CAS01060360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDKIC-DND-01062023-10-20
B432360CAS01070360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDKIC-DND-01072023-10-20
B432360CAS01080360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDKIC-DND-01082023-10-20
B432360CAS01090360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDKIC-DND-01092023-10-20
B432360CAS01100360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDKIC-DND-01102023-10-20
B432360CAS01130360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDKIC-DND-01132023-10-20
B432360CAS01200360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDKIC-DND-01202023-10-20
B432360CAS01230360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDKIC-DND-01232023-10-20
B432360CAS01250360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDKIC-DND-01252023-10-20
B432360CASSET00110360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDKIC-SET-00112023-10-20
04046963895860AESCULAPAesculap AGFS2272016-09-23
07613327599985MakoMAKO SURGICAL CORP.TKA 1.0.3 + THA 3.1.4 + PKA 3.0.42023-07-21
07613327600001MakoMAKO SURGICAL CORP.TKA 1.0.3+ THA 4.1.1 + PKA 3.0.42023-07-21
07613327600063MakoMAKO SURGICAL CORP.TKA 2.0.1+TKA 1.0.3+THA 4.0.2+PKA 3.0.42023-07-21
07613327600070MakoMAKO SURGICAL CORP.TKA 2.0.1+TKA 1.0.3+THA 4.1.1+PKA 3.0.42023-07-21
07613327601008MakoMAKO SURGICAL CORP.TKA 1.0.3 + THA 4.0.2 + PKA 3.0.42023-07-21
07613327541809N/AStryker Leibinger GmbH & Co. KG6003-700-0002023-05-11
07613327542202N/AStryker Leibinger GmbH & Co. KG81-800702023-05-11
07613327542219N/AStryker Leibinger GmbH & Co. KG6003-700-3002023-05-11
07613327542332N/AStryker Leibinger GmbH & Co. KG6003-710-0002023-05-11
07613327542363N/AStryker Leibinger GmbH & Co. KG6003-710-3002023-05-11
07613327542370N/AStryker Leibinger GmbH & Co. KG81-800712023-05-11
07613327542868N/AStryker Leibinger GmbH & Co. KG6007-700-0002023-05-11
07613327542875N/AStryker Leibinger GmbH & Co. KG6007-700-3002023-05-11
07613327542998N/AStryker Leibinger GmbH & Co. KG81-800722023-05-11
M588020004500370NavigantStereotaxis, Inc.5.1.02023-04-25
00841690194019OMNIBoticsOmni Life Science, Inc.TOOL 14-0202023-03-27
00841690194392OMNIBoticsOmni Life Science, Inc.NS-271142023-03-27
00841690194408OMNIBoticsOmni Life Science, Inc.NS-271132023-03-27
00841690194415OMNIBoticsOmni Life Science, Inc.NS-271122023-03-27
00841690194422OMNIBoticsOmni Life Science, Inc.NS-271112023-03-27
00841690194439OMNIBoticsOmni Life Science, Inc.NS-270172023-03-27
00841690194446OMNIBoticsOmni Life Science, Inc.NS-270162023-03-27
00841690194453OMNIBoticsOmni Life Science, Inc.NS-270152023-03-27
00841690194460OMNIBoticsOmni Life Science, Inc.NS-270142023-03-27
00841690194477OMNIBoticsOmni Life Science, Inc.NS-270132023-03-27
00841690194484OMNIBoticsOmni Life Science, Inc.NS-270122023-03-27
00841690194491OMNIBoticsOmni Life Science, Inc.NS-270112023-03-27
00841690194705OMNIBoticsOmni Life Science, Inc.2202-20002023-03-27
00841690194712OMNIBoticsOmni Life Science, Inc.0770-20002023-03-27
00887482040355Symmetry SheaASPEN SURGICAL PRODUCTS, INC.62-04452022-09-29
B432360CASSET00050360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDKIC-SET-00052022-09-07
04046963989101AESCULAPAesculap AGFS2292016-09-23
B432360CAS00240360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDKIC-DND-00242022-08-19