Chrysalis Intelligence · Sponsors · Tedan Surgical Innovations

Tedan Surgical Innovations

Sugar Land, TX, US · 2 510(k) clearances · 7 recalls

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Total clearances
2
2023-06-29 → 2026-04-26
Last 12 months
1
Product codes
2
Most recent
2026-04-26
Name variants in FDA filings: Tedan Surgical Innovations / TeDan Surgical Innovations, Inc.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
PDQ Neurosurgical Nerve Locator Class II Ear, Nose, Throat 1 2026-04-26
GXZ Electrode, Needle Class II Neurology 1 2023-06-29
Safety

Recalls (7)

Class I (serious)
0
Risk of injury / death
Total recalls
7
Currently ongoing
0
Most recent
2020-05-15
DateSeverityStatusRecall # ProductCodeReason
2020-05-15 Class II Terminated Z-2530-2020 PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in… — Lack of pouch seal. Product is labelled as sterile.
2020-05-15 Class II Terminated Z-2529-2020 PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in … — Lack of pouch seal. Product is labelled as sterile.
2020-05-15 Class II Terminated Z-2528-2020 PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in … — Lack of pouch seal. Product is labelled as sterile.
2020-05-15 Class II Terminated Z-2527-2020 PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterio… — Lack of pouch seal. Product is labelled as sterile.
2020-05-15 Class II Terminated Z-2526-2020 PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterio… — Lack of pouch seal. Product is labelled as sterile.
2020-05-15 Class II Terminated Z-2525-2020 3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior appro… — Lack of pouch seal. Product is labelled as sterile.
2020-05-15 Class II Terminated Z-2524-2020 3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior appro… — Lack of pouch seal. Product is labelled as sterile.
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2026-04-26 K253580 Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) PDQ Class II Ear, Nose, Throat
2023-06-29 K231691 Phantom XL Insulated Dilators GXZ Class II Neurology
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence