# 7D Surgical, Inc.

- Location (FDA's records): Toronto, CA
- FDA decisions: 10 (2016–2022): 10 510(k) clearances
- Names in FDA's records: 7D Surgical, Inc. (9); 7D Surgical (1)
- Product codes: OLO (7), HAW (3)
- 510(k) review time since 2016: median 88 days, against 96 for FDA's reviews in the same codes and years (7 of 10 faster)
- Predicates its devices cite: 13 (9 its own); citations of its devices by later devices: 16 (9 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Navigation, Inc.: 3 (https://510kreport.com/company/medtronic-navigation)
- Synaptive Medical, Inc.: 1 (https://510kreport.com/company/synaptive-medical)

## Firms that cite its devices most
- SeaSpine Orthopedics Corporation: 2 (https://510kreport.com/company/seaspine-orthopedics)
- Proprio, Inc.: 1 (https://510kreport.com/company/proprio)
- I.Z.I. Medical Products Corp.: 1 (https://510kreport.com/company/izi-medical-products)
- 7D Surgical ULC: 1 (https://510kreport.com/company/7d-surgical-ulc)
- Zeta Surgical, Inc.: 1 (https://510kreport.com/company/zeta-surgical)
- Pathkeeper Surgical, Ltd.: 1 (https://510kreport.com/company/pathkeeper-surgical)

## Its most-cited devices
- K180352: 7D Surgical System (2018), cited by 5
- K162375: Envision 3D: Image Guidance System (2016), cited by 5
- K192945: 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application (2019), cited by 2
- K192140: 7D Surgical System (2019), cited by 2
- K210457: 7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key (2021), cited by 1
- K181041: 7D Surgical System Cranial Application (2018), cited by 1

## Recent decisions
- K220522: 7D Surgical System - Percutaneous Application (7D Flash Frame) (May 20, 2022)
- K210457: 7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key (Jun 21, 2021)
- K210555: 7D Surgical System - Drill Guide (Mar 23, 2021)
- K201966: 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array (Sep 3, 2020)
- K192945: 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application (Nov 27, 2019)
- K192140: 7D Surgical System (Nov 5, 2019)
- K183276: 7D Surgical System (Aug 7, 2019)
- K181041: 7D Surgical System Cranial Application (Aug 8, 2018)

Source page: https://510kreport.com/company/7d-surgical