FDA Registration
Active
🇺🇸 United States
TECOMET, INC.
Reg #: 2132732
·
FEI: 1000306694
·
Expires 2026
Products
62
Proprietary Names
141
Establishment Types
4
Classifications
62
Registration Details
- Registration Name
- TECOMET, INC.
- Registration Number
- 2132732
- FEI Number
- 1000306694
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5307 95th Ave
- City
- KENOSHA
- State
- WI
- ZIP
- 53144
- Country
- US
Regulatory Submissions
- 510(k) Number
- K012105
Owner / Operator
- Firm Name
- Tecomet
- Operator Number
- 10031318
- Address
- 5307 95th Avenue
- City
- Kenosha
- State
- WI
- Postal Code
- 53144
- Country
- US
- Correspondent
- Julie Davis
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2012-09-15 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2012-12-14 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2015-03-30 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2013-12-18 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2012-12-21 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2012-12-21 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2012-09-16 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 2012-09-15 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 2013-02-20 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2012-09-16 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2020-09-04 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2012-09-16 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2012-12-14 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2013-12-18 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2012-12-14 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2012-12-14 |
| Instrument, Clip Removal | HBQ | Class 1 | Neurology | No | 2012-09-16 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2012-12-14 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2012-12-21 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2012-09-15 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2012-09-15 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2012-12-21 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2012-09-16 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2012-12-14 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2012-12-21 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2017-04-13 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2012-09-16 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2013-02-20 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2013-02-20 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2013-02-20 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2012-12-14 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2013-02-20 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2012-09-16 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2012-09-16 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2012-09-16 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2012-09-15 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2013-12-18 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2016-01-28 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2012-09-16 |
| Template | HWT | Class 1 | Orthopedic | No | 2012-09-16 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2012-12-21 |
| Applier, Hemostatic Clip | HBT | Class 1 | General, Plastic Surgery | No | 2012-09-16 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2012-12-14 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2012-12-21 |
| Driver, Surgical, Pin | GFC | Class 1 | General, Plastic Surgery | No | 2013-12-18 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2012-12-21 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 2013-02-20 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2012-09-15 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 2013-02-20 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2012-12-21 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2012-09-16 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2012-12-14 |
| Twister, Wire | HXS | Class 1 | Orthopedic | No | 2013-12-18 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2012-12-14 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2013-12-18 |
| Probe | HXB | Class 1 | Orthopedic | No | 2012-09-16 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2016-01-20 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 2013-01-14 |
| Forceps, Wire Holding | HYA | Class 1 | General, Plastic Surgery | No | 2020-08-26 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2012-09-16 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2012-12-21 |
| Bender | HXW | Class 1 | Orthopedic | No | 2012-09-16 |
Proprietary Names
BacFix Ti (Spinal Fixation System)
Silhouette (Prototypes)
Multiple Surgical Cutters
Multiple Screwdrivers
Multiple Orthopedic Screwdrivers
Beere Medical
Bethea Sheet Holder
Multiple Manual General Surgical Instruments
Sterilization wrap containers, trays, cassettes & other accessories
General Surgical Scissors
Torque Limiting Adapter
Weck Hem-O-Lock Endo Clip Remover
Weck Hem-O-Lock Clip Remover
InViZia (Anterior Cervical Plate Sys)
VIPER PRIME Locking Post Driver
Multiple Manual Surgical Chisels
Weck Raney Scalp Clip Appliers
BAYONETED BALL PROBE 110DEGSHT
ROD ROTATION FORCEPS
BAYONETED WOODSON PROBE 90DEG
BAYONETED WOODSON PROBE 45DEG
BAYONETED BALL PROBE 110DEGLNG
Multiple Bone Taps
Multiple Orthopedic Bone Taps
Multiple Wrenches
Evolution Broken Screw Remover
Multiple Trephines
SC - AcuFix (Ant-Cer)
Multiple Orthopedic Tamps
Multiple Tamps
ST360 (Spinal Fixation System)
Multiple Awls
Multiple Orthopedic Awls
Bit, Drill
Multiple Bending Plates
Multiple Trial Rods
Hem-O-Clip Plus
Hem-O-Clip Traditional
Horizon
Hem-O-Lock
VOLT Mini Fragment
VOLT Small Fragment
LUXOR RETRACTOR NERVE ROOT WIDE
Retractor
RETRACTOR NERVE ROOT NARROW
Multiple Surgical Pliers
Harmony (Anterior Instruments)
TiTLE 2 (Polyaxial Spinal System)
Dynesys
Multiple Orthopedic Probes
Multiple Probes
FORCEPS, WIRE HOLDING
BAYONETED KERRISON 3MM 40DEG
PITUITARY RONGEUR
TAMP OFFSET
CURETTE W/ TEETH 5MM STRAIGHT
DEFLECTION BEAM TORQUE WRENCH
Meniscal Transplant Set
MIS TORQUE LIMITING HANDLE
BAYONETED KERRISON 2MM 90DEG
Biosteon Wedge Interference Screw System
Forceps small
OASYS PLUS STRAIGHT SHAFT
XIA CUTTING PLIERS
OASYS PLUS DRILL GUIDE 10/12 MM
BAYONETED KERRISON 4MM UPBITE
ROD CUTTER
TAMP STRAIGHT
VLIFT-S CALIPER
AXSOS - INSTRUMENTS
OASYS PLUS FLEXIBLE SHAFT
TORQUE WRENCH 3/8 DRIVE
CALIPER
BAYONETED KERRISON 2MM 40DEG
XIA T-RATCHET HANDLE
PLATE HOLDER
TLIF BONE INSERTER
RADIUS CANNULATED RATCHETING T-HANDLE
BAYONETED KERRISON 3MM 90DEG
SMALL ROD CUTTER
XIA CANN RND HANDLE RATCHET
Universal Chuck
BAYONETED KERRISON 5MM 40DEG
RADIUS CANNULATED STD RATCHETING HANDLE
CURETTE W/ TEETH 5MM UP
PITUITARY RONGEUR UP
BAYONETED PENFIELD PULL NO.2
Nex-Link OCT
Harmony
SC - AcuFix (Ant-Cer, BacFix)
Unknown
MINIT (Cervico-Thoratic Fixation Sys)
Thoracolumbar (Common)
General Instruments
Orthopedic Manual Surgical Instrument (Implant Remover) for Unison®-C Anterior Cervical Fixation System
Multiple Manual Orthopedic Instruments
Multiple Manual Surgical Instruments
T SHAPE TORQUE LIMITING HANDLE (SMALL)
T-HANDLE
FRENCH BENDER
T SHAPE TORQUE LIMITING HANDLE FOR TITANIUM
BAYONETED PENFIELD PUSH NO.4
OASYS TORQUE WRENCH
LIPPED SUCTION TIP WITH BEND
BAYONETED KERRISON 5MM 90DEG
Conical Extractor femal 3,0
Conical Extractor femal 4,0
PITUITARY RONGEUR STR
MICRO SCISSOR SINGLE ACTION
OASYS CONNECTOR CLIP INSERTER
BAYONETED CURETTE DOWN
SUCTION TUBE STYLET
BAYONETED KERRISON 4MM 40DEG
BAYONETED NERVE HK 90DEG BLUNT
XIA CANN T-HANDLE RATCHET
T HANDLE
Universal ACL Instrumentation
ROD-PLATE BENDER
OASYS PLUS SHORT QUICK RELEASE HDLE
BAYONETED PENFIELD PULL NO.4
BAYONETED CURETTE UP
OASYS PLUS ANGLED DRIVER
CURETTE W/ TEETH 5MM DOWN
BAYONETED KERRISON 2MM UPBITE
BAYONETED CURETTE STRAIGHT
PLATE BENDER
OASYS PLUS SHORT DRIVER
Forceps large
130 IN-LB TORQUE WRENCH
SUCTION TIP WITH BEND
XIA ROUND-RATCHET HANDLE
DUAL PURPOSE HANDLE
BAYONETED KERRISON 4MM 90DEG
SYPERT RONGEUR
RATCHET T HANDLE
BAYONETED PENFIELD PUSH NO.2
PITUITARY RONGEUR DOWN
Discectomy
French Bender
Multiple Orthopedic Benders
Multiple Benders
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device