Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031081659

FEI Number

3031081659

Entity Name

PRO SURGICAL, INC.

City/State/Country

Carlsbad, CA, US

Establishment Address

1910 Palomar Point Way, Suite 201, Carlsbad, CA 92008, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Pro Surgical, Inc. (Owner Number: 10090745)

Owner / Operator Contact Address

1910 Palomar Point Way, Suite 201, Carlsbad, CA 92008, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ProAM ALIF System Pro Surgical Orthopedic manual instruments

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2024-12-09
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2024-12-09
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2024-05-08
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-05-08
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2025-01-13

Official Correspondent

Jason Blain

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Pro Surgical, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K142269	Reliance Medical Systems, LLC	Reliance Cervical IBF System	2015-06-09
K122085	Omni Surgical, LP Dba Spine360	STINGRAY CERVICAL CAGE	2012-10-17
K120275	Synthes (Usa), LLC	SYNTHES ACIS/VERTEBRAL SPACER CR	2012-05-25
K192492	Astura Medical, LLC	EL CAPITAN Anterior Lumber Interbody System	2020-04-21
K212498	Nexus Spine, LLC	Stable-L Standalone Lumbar Interbody System	2022-03-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

Registration Number	Establishment Name	Location
3017936978	CARLSMED, INC.	Carlsbad, CA, US
3012447612	Highridge Medical, LLC	Westminster, CO, US
3016084569	MOUNT MFG	Marquette, MI, US
1424263	Isomedix Operations, Inc.	Libertyville, IL, US
3018210489	NEXUS SPINE, LLC.	Draper, UT, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031081659. Last updated year: 2026. Please use registration number 3031081659 when referencing this establishment in official correspondence.