7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key— 510(k) K210457

Clearance details

Applicant

7D Surgical, Inc.

Product code

Code OLO

Device class

Class 2

Regulation

21 CFR 882.4560

Advisory panel

Neurology

Date received

2021-02-16

Decision date

2021-06-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Toronto, CA

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• K262121 — Ion-L Navigated Instruments2026-07-24

• K210555 — 7D Surgical System - Drill Guide2021-03-23
• K201966 — 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array2020-09-03
• K192945 — 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application2019-11-27
• K192140 — 7D Surgical System2019-11-05
• K183276 — 7D Surgical System2019-08-07

Death

11

Injury

2,799

Malfunction

11,105

Other

1

Total

13,916

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →