ALVA PROTOTYPES INC

FDA Device Registration & Listing · Pottstown, PA, US · Registration 3012234585

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
3012234585
FEI Number
3012234585
Entity Name
ALVA PROTOTYPES INC
City/State/Country
Pottstown, PA, US
Establishment Address
300 OLD READING PIKE STE 1A, Pottstown, PA 19464, US
Establishment Type(s)
Remanufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Alva Prototypes Inc (Owner Number: 10055714)
Owner / Operator Contact Address
10 Quinter St., Pottstown, PA 19464, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

T-15 Screwdriver Ratcheting Driver Locking Screwdriver Posterior Fixation Driver Self-Retaining Bone Screw Driver Cannulated Driver Angled Driver with Counter Torque Altos Long Sleeve Driver Fixed Angle Screwdriver Angled Driver Pedicle Screwdriver Perc Screwdriver STALIF C Ball Joint Screwdriver 35-Degree Angled Driver Polyaxial Driver Orthos Driver Center Post Removal Driver Posterior Cervical Driver Locking Cap Driver Final Driver Driver T30 Screwdriver Ball Joint Screwdriver Midline Screwdriver U-Joint Driver Navigation Driver Tulip Cap Driver Self-Retaining Driver Hex Driver Screwdriver Cannulated T25 Driver El Capitan Driver Tip MIS Nav Shank Driver Admiral ACP Screwdriver Implant Driver Altos Screwdriver T20 Retention Driver Reform Driver Power T Driver Driver Bit STALIF M Screwdriver 45-degree Screwdriver Screwdriver with Lock and Sleeve T-20 Self-retaining Driver Tulip Cap Driver – Extended NorthStar Poly Driver TIO Screwdriver Mariner Screwdriver Custom Driver 35-degree Screwdriver T10 Female Driver ALIF Driver T25 Retention Driver T25 Universal Driver Short Final Driver Retention Screwdriver Introducer Components for Orthos Driver Nav Driver Small Thoracic Curved Lenke Probe Probe Pedicle Probe Lenke Probe Reamer Probe Ball Probe Extended Probe Bone Probe Straight Probe Custom Probe Prodisc L Chisel Corner Chisel Hemi-chisel Hemi-chisel Prodisc L Right Retractor Nerve Root Retractor Retractor Blade Retractor Retractor Frame Retractor Telescoping Blade Tissue Retractor Left Retractor TLIF Retractor Slap Hammer Straight Impactor Talar Impactor Offset Impactor INF Plate Impactor Slap Hammer Adapter Tibial Impactor Osteotome, Offset Osteotome, Osteotome Wedge Tap Aspirator Tap Iliac Tap Cannulated Tap MIS Nav Tap Occipital Tap Tap Sleeve Long Tap Solid Awl Tipped Tap Reform Tap Bone Tap STALIF C Reamer Articulating Midline Reamer Articulating Reamer Flexible Reamer Reamer Tamp, Angled Tamp, Midline Tamp, PDL Tamp Extra Long Counter Torque Custom Counter Torque C-Torque MIS Inner Counter Torque Wrench Short Counter Torque Crossbar Counter Torque Counter Torque Wrench Counter Torque Open Counter Torque OCT Offset Counter Torque MIS Counter Torque Long Counter Torque Clip Inserter Rail Drill Guide Distractor Fixed Angle Drill Guide Straight inserter Custom Paddle Shaver ALIF Disc Space Distractor Inserter With Retraction Prodisc Repositioner Lordotic Paddle Distractor ACIF Trial SAZ Inserter Blocking Plate Inserter Starter Trial PDC Trial Tibial Trial STALIF L Inserter, Offset Threaded Rod Reducer Cobb Prodisc Inserter Fixed Drill Guide Cervical Trial Distractor Fork Low Profile Inserter, Midline ALIF Distractor Drill Implant Inserter Pistol Grip Reducer ALIF Trial Staple inserter Inserter Drill Guide Angled Distractor Lateral Inserter ALIF Inserter Angled, Threaded Inserter Angled Inserter Short Inserter Bearing Implant Inserter Pusher-distractor Dilator Bearing Inserter All-In-One Trial Graft Inserter Cervical Inserter Vivo Trial Modified Dilator PLIF Trial Ankle Distractor Rod Distractor Repositioner Tip TLIF Inserter Inserter Delta Inserter Parallel Distractor Variable Angle Inserter Anterior Cobb Guide Inserter Bullet Distractor FORTOS-C Fixed Angle Drill Guide PDC Inserter Angled Lollipop Trial ACDF Inserter ENZA 2 Inserter Screw Inserter Lollipop Trial Inserter/Tensioner ALIF Paddle Distractor Vivo Inserter Flat Cobb Cervical Distractor Threaded Dilator Regatta Angled Inserter Rasp Trial Monaco Rod Reducer Cone Guide Inserter Overhead Reducer Posterior Paddle Shaver Simple Inserter Tower Reducer Stopless Trial PDC Trial with Screw Guide MD5 Trial Wedge Trial Vertebral Distractor Coveris Trial Prodisc C Inserter Modular Distractor Spreader Arm PDL Trial ALIF Shaver Lordotic Trial H-Graft Inserter Bent Imola Inserter Bar Inserter Angled Drill Assembly AIO Inserter MIS Screw Inserter Trial Repositioner Trial Inserter MIS Inserter Undersized Regatta Trial Cornice Inserter Sochi Threaded Reducer ENZA A Angle Inserter Monaco Threaded Reducer Reducer Tapered Trial ENZA 2 Bar Inserter TLIF Articulating Inserter Locking Set Screw Inserter Modular Trial Trial Post Right-Angle Drill Prodisc L Trial ALIF 25 mm Elevator Cobb Paddle Distractor Bent Cobb ACIF Trial Drill Guide Rod Inserter Tab Reducer PDC Repositioner Peg Drill Trial Stem Explorer TA Inserter Double Drill Guide Drill Guide Set Screw Inserter Talar Trial Shaver Rod Reducer MIS Rod Inserter Pistol Reducer Distraction Forceps Vertebral Body Spreader Talar Rail Rasp Saw Rasp Retro Rasp One-sided Rasp Trial Rasp Rasp KinosTAR STALIF C Ball-Joint Awl Angled Awl Punch Awl Curved Awl T-Handle Awl, Extended Lumbar Punch Awl Guided Straight Awl STALIF C U-Joint Awl Guided Awl Teardrop Curette Bayonetted Curette Up-biting Curette Straight Up-angled Curette 90-degree Curette Bayonetted Box Curette

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HXX Screwdriver Orthopedic Class 1 888.4540 2017-09-21
HXB Probe Orthopedic Class 1 888.4540 2023-02-08
KDG Chisel (Osteotome) General, Plastic Surgery Class 1 878.4820 2023-01-30
GAD Retractor General, Plastic Surgery Class 1 878.4800 2023-02-08
HWA Impactor Orthopedic Class 1 888.4540 2023-01-30
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2023-02-08
HWX Tap, Bone Orthopedic Class 1 888.4540 2023-02-22
HTO Reamer Orthopedic Class 1 888.4540 2023-02-08
HXG Tamp Orthopedic Class 1 888.4540 2023-02-22
HXC Wrench Orthopedic Class 1 888.4540 2023-02-22
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2023-02-22
GAC Rasp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2023-02-08
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2021-12-10
HWJ Awl Orthopedic Class 1 888.4540 2023-01-30
HTF Curette General, Plastic Surgery Class 1 878.4800 2023-01-30

Official Correspondent

Robert Trout III

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Alva Prototypes 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
K894785 Fdt Precision Machine Co., Inc. SURGICAL CHISEL/OSTEOTOME 1989-08-18
K922626 Andronic Devices, Ltd. ADEPT INSTRUMENT POSITIONING ACCESSORY 1992-10-19
K820290 The Anspach Effort, Inc. SELF RETAINING RETRACTOR FOR HAND SURG 1982-03-05
K760422 Cutter Laboratories, Inc. SURGICAL RETRACTOR 1976-08-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-2014 Aesculap, Inc. 1
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0010-2008 N/A 1
EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
Z-0021-2015 Biomet, Inc. 1
Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012234585. Last updated year: 2026. Please use registration number 3012234585 when referencing this establishment in official correspondence.
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