PACE SURGICAL

FDA Device Registration & Listing · Malvern, PA, US · Registration 3042765769

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3042765769
FEI Number
3042765769
Entity Name
PACE SURGICAL
City/State/Country
Malvern, PA, US
Establishment Address
7 Great Valley Pkwy Ste 295, Malvern, PA 19355, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Pace Surgical (Owner Number: 10094629)
Owner / Operator Contact Address
7 Great Valley Parkway, Suite 295, Malvern, PA 19355, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Pace Surgical Instruments Pace Surgical Instruments Ultra Compression Screw System Pace Surgical Instruments Pace Surgical Instruments Pace Surgical Instruments

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2026-02-03
HWX Tap, Bone Orthopedic Class 1 888.4540 2026-02-03
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2025-12-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-12-11
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2026-02-03
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2026-02-03
HXX Screwdriver Orthopedic Class 1 888.4540 2026-02-03

Official Correspondent

Kaileen Osisek

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Pace Surgical
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
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27
K972722 Orthopedic Designs, Inc. ULTIMATE COMPRESSION SCREW SYSTEM 1998-01-23
K192974 Tyber Medical, LLC Tyber Medical Trauma Screw 2020-01-08
K082949 OrthoPediatrics Corp. ORTHOPEDIATRICS BONE SCREWS 2008-11-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2016 Zimmer, Inc. 1
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

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3001397320 ROECHLING MEDICAL ROCHESTER L.P. Rochester, NY, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042765769. Last updated year: 2026. Please use registration number 3042765769 when referencing this establishment in official correspondence.
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