THEKEN COMPANIES, LLC

FDA Device Registration & Listing · Akron, OH, US · Registration 3002498892

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
3002498892
FEI Number
3002498892
Entity Name
THEKEN COMPANIES, LLC
City/State/Country
Akron, OH, US
Establishment Address
1800 Triplett Blvd, Akron, OH 44306, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Theken Companies, LLC (Owner Number: 10050903)
Owner / Operator Contact Address
1800 Triplett Blvd, Akron, OH 44306, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

RASP QUICK CONNECT/ DRIVER HANDLE OSTEOTOME DEPTH GAUGE DRILL RETRACTOR iNSitu Total Hip System INSERTERADAPTER iNSitu Total Hip System TEMPLATETRIAL TheRay Collared and Collarless Femoral Stem IMPACTOR iNSitu Total Hip System EXTRACTOR REAMER eCeramic Femoral Heads BROACH DRILL GUIDE HAMMER FORCEPS PLANAR

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HTR Rasp General, Plastic Surgery Class 1 878.4800 2018-02-12
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2018-02-12
GFI Osteotome, Manual General, Plastic Surgery Class 1 878.4800 2018-02-09
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2018-02-09
HTW Bit, Drill Orthopedic Class 1 888.4540 2018-02-12
GAD Retractor General, Plastic Surgery Class 1 878.4800 2018-02-09
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2019-12-19
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2019-12-19
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2019-12-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2019-12-19
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2018-02-12
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2016-11-09
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2016-11-09
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2016-11-09
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2016-11-09
HWT Template Orthopedic Class 1 888.4800 2018-02-12
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2024-11-11
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2024-11-11
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2024-11-11
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2024-11-11
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2024-11-11
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2024-11-11
HWA Impactor Orthopedic Class 1 888.4540 2018-02-12
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2019-12-19
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2019-12-19
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2019-12-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2019-12-19
HWB Extractor Orthopedic Class 1 888.4540 2018-02-12
HTO Reamer Orthopedic Class 1 888.4540 2018-02-12
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2024-01-15
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2024-01-15
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2024-01-15
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2024-01-15
HTQ Broach Orthopedic Class 1 888.4540 2018-02-12
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2018-02-09
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2018-02-09
HTD Forceps General, Plastic Surgery Class 1 878.4800 2018-02-09
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2018-02-12

Official Correspondent

Garrett Spurgeon

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Theken Companies, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3010197296 VisionAir Solutions Akron, OH, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
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
K201660 Kyocera Medical Technologies, Inc. KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System 2020-07-16
K030151 Hayes Medical, Inc. CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM 2003-04-10

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-0007-2023 Zimmer, Inc. 2
G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002498892. Last updated year: 2026. Please use registration number 3002498892 when referencing this establishment in official correspondence.
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