FDA Registration
Active
🇺🇸 United States
AUTOCAM MEDICAL
Reg #: 3010047402
·
FEI: 3010047402
·
Expires 2026
Products
35
Proprietary Names
0
Establishment Types
1
Classifications
35
Registration Details
- Registration Name
- AUTOCAM MEDICAL
- Registration Number
- 3010047402
- FEI Number
- 3010047402
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4152 (4162) East Paris Ave SE
- City
- Kentwood
- State
- MI
- ZIP
- 49512
- 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 |
|---|---|---|---|---|---|
| Extractor | HWB | Class 1 | Orthopedic | No | 2015-05-01 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2013-01-31 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2013-01-31 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2013-01-31 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2013-01-07 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2022-02-23 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2014-08-19 |
| Template | HWT | Class 1 | Orthopedic | No | 2015-05-01 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2018-11-01 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2013-01-18 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | 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 Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2015-05-01 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2015-05-01 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2013-01-22 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2021-07-28 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2020-01-21 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2020-01-21 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2013-01-18 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2020-09-23 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2018-01-31 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2013-01-18 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2021-07-28 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2015-05-01 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-18 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2013-01-18 |
| Vitrectomy, Instrument Cutter | MLZ | Class 2 | Ophthalmic | No | 2015-02-26 |
| Apparatus, Cautery, Radiofrequency, Ac-Powered | HQR | Class 2 | Ophthalmic | No | 2015-02-26 |
| Unit, Phacofragmentation | HQC | Class 2 | Ophthalmic | No | 2015-02-26 |
| Lens, Guide, Intraocular | KYB | Class 1 | Ophthalmic | No | 2015-02-26 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2013-01-31 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2026-01-14 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2013-01-18 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2019-12-19 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2019-12-19 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)