TESCO ASSOCIATES, INC.

FDA Device Registration & Listing · TYNGSBORO, MA, US · Registration 1226183

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
1226183
FEI Number
3002757549
Entity Name
TESCO ASSOCIATES, INC.
City/State/Country
TYNGSBORO, MA, US
Establishment Address
500 BUSINESS PARK DR., TYNGSBORO, MA 01879, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
TESCO ASSOCIATES, INC. (Owner Number: 9034850)
Owner / Operator Contact Address
500 BUSINESS PARK DR., --, Tyngsboro, MA 01879, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Bio-button Arthrex Biocomposite Interference Screw Arthrex Bio-Post and Washer

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2023-09-29
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-09-29
KGS Retention Device, Suture General, Plastic Surgery Class 1 878.4930 2012-12-05
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2012-12-05
GAS Suture, Nonabsorbable, Synthetic, Polyester General, Plastic Surgery Class 2 878.5000 2012-12-05
MGB Device, Hemostasis, Vascular Unknown Class 3 N/A 2023-09-29
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2012-12-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-05
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2012-12-05
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2012-12-05
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2019-12-19
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-04
MNU Staple, Absorbable Orthopedic Class 2 888.3030 2012-12-04
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2012-12-04
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-04

Official Correspondent

Chris Thatcher

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TESCO ASSOCIATES, 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
K203334 Acuitive Technologies, Inc. The Citrefix Knotless Suture Anchor 2021-02-05
K243467 Osteonic Co., Ltd. Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) 2024-12-03
K213415 OSSIO , Ltd. OSSIOfiber Suture Anchor 2022-03-28
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27

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
3021179744 VIEW POINT MEDICAL, INC. Carlsbad, CA, US
3013649990 HEALTH BEACONS, INC. Marlborough, MA, US
3026851515 VDL TBP ELECTRONICS Dirksland Zuid-Holland, NL
3015924373 AUSA Medical Device Pvt Ltd Bangalore Karnataka, IN
2029275 Sterigenics U.S., LLC Corona, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1226183. Last updated year: 2026. Please use registration number 1226183 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.