Chrysalis Intelligence · Sponsors · Pega Medical, Inc.

Pega Medical, Inc.

Laval, CA · 3 510(k) clearances · 1 recalls

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Total clearances

3

2020-06-24 → 2022-10-24

Last 12 months

0

Product codes

2

Most recent

2022-10-24

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
HSB	Rod, Fixation, Intramedullary And Accessories	Class II	Orthopedic	2	2021-05-26
OBT	Plate, Bone, Growth Control, Pediatric, Epiphysiodesis	Class II	Orthopedic	1	2022-10-24

Safety

Recalls (1)

Class I (serious)

0

Risk of injury / death

Total recalls

1

Currently ongoing

0

Most recent

2020-04-03

Date	Severity	Status	Recall #	Product	Code	Reason
2020-04-03	Class III	Terminated	Z-2038-2020	Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM …	—	The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.

Filings

All 510(k) clearances (3)

Date	K-number	Device	Code	Class	Specialty
2022-10-24	K220190	The GIRO Growth Modulation System	OBT	Class II	Orthopedic
2021-05-26	K211292	Fassier-Duval Telescopic IM System	HSB	Class II	Orthopedic
2020-06-24	K192710	The Simple Locking Intramedullary (Slim) System	HSB	Class II	Orthopedic