510(k) K172518
- Device
- Spineology Navigation Instruments
- Applicant
- Spineology Inc.
- 510(k) number
- K172518
- Product code
- OLO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-01-05
- Date received
- 2017-08-21
- Regulation
- 882.4560
- Classification name
- Orthopedic Stereotaxic Instrument
- Medical specialty
- Neurology
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jacqueline Hauge
- Address
- 7800 3rd St. N. Suite 600 Saint Paul MN US 55128 55128
FDA Registration Numbers#
- 2133786
- 2249615
- 3009380063
- 3009165919
- 8043933
- 3010663372
- 1424434
- 1644408
- 3015967359
- 3025603301
- 3006493760
- 3016443334
- 3005497913
- 3016496998
- 3034676720
- 3013404959
- 3014725904
- 3007441485
- 3025783933
- 3013682146
- 3013485140
- 3014655115
- 3005874553
- 9611112
- 3006128100
- 3010232390
- 3018565653
- 3021060474
- 3014411622
- 9612420
- 3009394448
- 9611827
- 3004060780
- 3017492965
- 1720929
- 3027153110
- 3017406274
- 3010173425
- 3007728266
- 1835251
- 1123169
- 3010120339
- 3002743211
- 1835444
- 3000270450
- 9615128
- 3010041499
- 3010863450
- 3043520111
- 3009049161
- 1835572
- 1450662
- 3040312029
- 3010047454
- 3040335671
- 2133772
- 2647346
- 3003661942
- 3003596442
- 3003541440
- 2011171
- 8043792
- 3003935342
- 3008868758
- 3010049501
- 3017823294
- 3011674645
- 3009871135
- 3016075969
- 3010197239
- 3011656326
- 1935627
- 1319660
- 3009888740
- 3012911444
- 3006984710
- 3010141593
- 3015876273
- 3025110439
- 3003139373
Source Documents#
Other 510(k) Records For Product Code OLO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262567 | GPS Ankle | Blue Ortho | 2026-10-26 |
| K260403 | 7D Surgical System (10-0001) | 7D Surgical ULC | 2026-10-19 |
| K263234 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2026-10-16 |
| K263154 | CarboClear® Cervical Navigated Instruments | CarboFix Orhtopedics , Ltd. | 2026-10-09 |
| K262257 | Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine | Brainlab SE | 2026-09-30 |
| K262506 | Remex Spine Surgery Navigation - Universal Instruments | Remex Medical Corp. | 2026-08-20 |
| K261410 | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) | Suite 201, National Innovation Centre | 2026-07-30 |
| K261205 | SPINEART Navigation Instrument System | Spineart SA | 2026-07-29 |
| K261024 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2026-07-24 |
| K262121 | Ion-L Navigated Instruments | SurGenTec, LLC | 2026-07-24 |
| K261113 | Op.n™ Spine Navigation and Robotic Guidance | Ecential Robotics | 2026-07-22 |
| K261852 | OTS Hip | Ortoma AB | 2026-07-01 |
| K253921 | VERTICALE® Navigation Instruments | Silony Medical GmbH | 2026-06-26 |
| K260480 | VELYS™ Robotic-Assisted Solution | Depuy Ireland UC | 2026-06-25 |
| K260369 | Dynamis Robotic Surgical System | LEM Surgical AG | 2026-06-20 |
Legacy Summary#
summary
FDA Review#
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