Who else makes this device?

Name: Passer
Brand: Passer

Orthopedic › SurgicalAccessories, Fixation, Spinal Intervertebral Body

Passer

Catalogue number Gen 3, listed by Empirical Spine, Inc., United States, under Accessories, Fixation, Spinal Intervertebral Body. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

Who Else Makes It

Registered in Shanghai.

Chinese manufacturers registered for FDA product code LYQ
Manufacturer	City	Province	Registered as	Device types
Shanghai Medical Instruments (Group) Ltd. Corp.	Shanghai	Shanghai	Contract manufacturer	235

Record

Regulatory record for Passer
Listed by	Empirical Spine, Inc., United States
FDA product code	LYQ
Device type	Accessories, Fixation, Spinal Intervertebral Body
Device class	Class 1
Regulation	21 CFR 888.4540
Establishment	Manufacturer
510(k)	P220031
Record published	2026-03-27

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for Passer
Catalogue number	Size	Status
Gen 3		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Integrate-C	Happe Spine	124
SureMAX-SA	Additive Implants	34
SureMAX	Additive Implants	16
PTS	PT Solutions, LLC	12
Riva Posterior Fixation System	Xenix Medical	8
KeyLift™	Flospine LLC	6
Riva Pedicle Screw System	Xenix Medical	6
Coda™ Anterior Cervical Plate System	Pioneer Surgical Technology, Inc.	3
Distraction Screw, 12MM Pouch	Medline Industries, Inc.	2
Distraction Screw, 14MM pouch	Medline Industries, Inc.	2
LUX Expandable Interbody System	Xenix Medical	2
Distraction Pin, 12MM Pouch	Medline Industries, Inc.	2

Showing 12 of 22. All products under Accessories, Fixation, Spinal Intervertebral Body

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.