RAM PRECISION INDUSTRIES INC

FDA Device Registration & Listing · Dayton, OH, US · Registration 3005004799

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
3005004799
FEI Number
3005004799
Entity Name
RAM PRECISION INDUSTRIES INC
City/State/Country
Dayton, OH, US
Establishment Address
11125 Yankee St, Dayton, OH 45458, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
RAM PRECISION INDUSTRIES INC (Owner Number: 10043731)
Owner / Operator Contact Address
11125 Yankee St., Dayton, OH 45458, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

osteo-WEDGE Bone Plate 08mm Implant osteo-Wedge 3mm x 16mm Locking Bone Screw Implant osteo-Wedge 2.5mm x 10mm Locking Bone Screw Implant osteo-WEDGE TemporaryTack 2.4mm x 10mm osteo-Wedge 3mm x 20mm Locking Bone Screw Implant osteo-Wedge 2.5mm x 18mm Locking Bone Screw Implant osteo-Wedge 3mm x 08mm Locking Bone Screw Implant osteo-Wedge 3mm x 22mm Locking Bone Screw Implant osteo-WEDGE Bone Plate 02mm Implant osteo-Wedge 2.5mm x 26mm Locking Bone Screw Implant osteo-WEDGE Bone Plate 06mm Implant osteo-WEDGE Bone Plate 04mm Implant osteo-Wedge 3mm x 26mm Locking Bone Screw Implant osteo-WEDGE TemporaryTack 2.4mm x 08mm osteo-Wedge 3mm x 24mm Locking Bone Screw Implant osteo-Wedge 2.5mm x 14mm Locking Bone Screw Implant osteo-WEDGE Bone Plate 10mm Implant osteo-Wedge 2.5mm x 12mm Locking Bone Screw Implant osteo-Wedge 2.5mm x 24mm Locking Bone Screw Implant osteo-WEDGE TemporaryTack 2.4mm x 12mm osteo-Wedge 3mm x 12mm Locking Bone Screw Implant osteo-Wedge 2.5mm x 20mm Locking Bone Screw Implant osteo-WEDGE Bone Plate 00mm Implant osteo-Wedge 3mm x 18mm Locking Bone Screw Implant osteo-Wedge 2.5mm x 16mm Locking Bone Screw Implant osteo-Wedge 3mm x 14mm Locking Bone Screw Implant osteo-Wedge 3mm x 10mm Locking Bone Screw Implant osteo-Wedge 2.5mm x 08mm Locking Bone Screw Implant osteo-Wedge 2.5mm x 22mm Locking Bone Screw Implant HyproCure Sinus Tarsi Stent ONE TRAY HyProCure Driver HyProCure II Driver osteo-WEDGE Drill Guide osteo-WEDGE Driver HyProCure Sizer 06 osteo-WEDGE Depth Gauge Sleeve HyProCure Sizer 08 HyProCure Sizer 05 HyProCure Sizer 07 osteo-WEDGE Depth Gauge HyProCure Sizer 10 HyProCure Sizer 09

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-03-03
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-03-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-01
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2014-04-23
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2017-03-03

Official Correspondent

Rick Mount

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RAM PRECISION INDUSTRIES 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
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-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.
Z-0043-2018 MicroPort Orthopedics Inc. 2
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

Similar Registrations

Registration Number Establishment Name Location
3013843055 BEIJING AK MEDICAL CO, LTD Changping District Beijing, CN
3022777867 FIXIER S.A. DE C.V. Doctor Mora Guanajuato, MX
3017209758 NEBULA SURGICAL PRIVATE LIMITED Rajkot Gujarat, IN
3015410662 Jabil Inc. (Wilson Drive) W Chester, PA, US
8043862 AAP IMPLANTATE AG BERLIN, DE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005004799. Last updated year: 2026. Please use registration number 3005004799 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.