FDA Registration
Active
🇺🇸 United States
THEKEN COMPANIES, LLC
Reg #: 3002498892
·
FEI: 3002498892
·
Expires 2026
Products
25
Proprietary Names
23
Establishment Types
3
Classifications
25
Registration Details
- Registration Name
- THEKEN COMPANIES, LLC
- Registration Number
- 3002498892
- FEI Number
- 3002498892
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1800 Triplett Blvd
- City
- Akron
- State
- OH
- ZIP
- 44306
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191936
Owner / Operator
- Firm Name
- Theken Companies, LLC
- Operator Number
- 10050903
- Address
- 1800 Triplett Blvd
- City
- Akron
- State
- OH
- Postal Code
- 44306
- Country
- US
- Correspondent
- Garrett Spurgeon
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2018-02-12 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2018-02-12 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2018-02-09 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2018-02-09 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2018-02-12 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2018-02-09 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2019-12-19 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2019-12-19 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2019-12-19 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2019-12-19 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2018-02-12 |
| Template | HWT | Class 1 | Orthopedic | No | 2018-02-12 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2024-11-11 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2024-11-11 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2018-02-12 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2018-02-12 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2018-02-12 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2018-02-12 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2018-02-09 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2018-02-09 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2018-02-09 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2018-02-12 |
| Hook, Bone | KIK | Class 1 | General, Plastic Surgery | No | 2018-02-12 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2018-02-09 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2018-02-12 |
Proprietary Names
RASP
QUICK CONNECT/ DRIVER HANDLE
OSTEOTOME
DEPTH GAUGE
DRILL
RETRACTOR
iNSitu Total Hip System
INSERTERADAPTER
TEMPLATETRIAL
TheRay Collared and Collarless Femoral Stem
IMPACTOR
EXTRACTOR
REAMER
eCeramic Femoral Heads
BROACH
DRILL GUIDE
HAMMER
FORCEPS
PLANAR
BONE HOOK
Sterilization Tray
iNSitu Bipolar Hip System
SCREWDRIVER
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198