FDA Registration
Active
🇺🇸 United States
SOUTHEASTERN TECHNOLOGY dba Autocam Medical
Reg #: 1057425
·
FEI: 1000221916
·
Expires 2026
Products
81
Proprietary Names
1
Establishment Types
1
Classifications
81
Registration Details
- Registration Name
- SOUTHEASTERN TECHNOLOGY dba Autocam Medical
- Registration Number
- 1057425
- FEI Number
- 1000221916
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 905 INDUSTRIAL DR
- City
- Murfreesboro
- State
- TN
- ZIP
- 37129
- Country
- US
Owner / Operator
- Firm Name
- Autocam Medical
- Operator Number
- 9034301
- Address
- 3607 Broadmoor Avenue SE
- City
- Kentwood
- State
- MI
- Postal Code
- 49512
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2013-01-07 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2013-01-07 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2015-04-10 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2015-05-01 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2015-05-01 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2015-05-01 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2015-05-01 |
| Ankle Arthroplasty Implantation System | OYK | Class 2 | Orthopedic | No | 2015-05-01 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2013-01-31 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2015-05-01 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2015-04-10 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2015-05-01 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2015-05-01 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2015-05-01 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2015-04-10 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-01-04 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-01-04 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2015-05-01 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2015-05-01 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2015-04-13 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2015-05-01 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2015-05-01 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2015-04-13 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2013-01-03 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-01-03 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2018-07-20 |
| External Mandibular Fixator And/Or Distractor | MQN | Class 2 | Dental | No | 2015-05-01 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2013-01-22 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2016-03-09 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2015-05-01 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2025-03-05 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2013-01-18 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2013-01-22 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2013-01-22 |
| Probe | HXB | Class 1 | Orthopedic | No | 2015-04-10 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2015-04-10 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2015-05-01 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2013-01-18 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2015-05-01 |
| Brush, Biopsy, General & Plastic Surgery | GEE | Class 1 | General, Plastic Surgery | No | 2015-05-01 |
| Template | HWT | Class 1 | Orthopedic | No | 2015-05-01 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2015-04-10 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2015-04-10 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-18 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2013-01-18 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2013-01-18 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2015-05-01 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2015-05-01 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2015-05-01 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2015-05-01 |
| Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer | KRQ | Class 2 | Orthopedic | No | 2015-05-01 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2015-05-01 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2015-05-01 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2015-05-01 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2015-05-01 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2015-04-10 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2015-05-01 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2015-05-01 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2015-04-10 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2015-05-01 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2015-05-01 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2015-05-01 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2015-05-01 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2015-05-01 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2015-05-01 |
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 2020-04-01 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2015-05-01 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2015-04-13 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2013-01-22 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2015-05-01 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2021-06-03 |
| Prosthesis, Condyle, Mandibular, Temporary | NEI | Class 2 | Dental | No | 2015-05-01 |
| Driver, Surgical, Pin | GFC | Class 1 | General, Plastic Surgery | No | 2015-05-01 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2015-04-10 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2015-05-01 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2015-05-01 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2015-05-01 |
| Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented | MJT | Class 3 | Unknown | No | 2013-01-22 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2015-05-01 |
| Retractor, Self-Retaining, For Neurosurgery | GZT | Class 2 | Neurology | No | 2013-01-04 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2013-01-18 |
Proprietary Names
CLAW® II A PLATE LARGE LT
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)