FDA Registration
Active
🇺🇸 United States
MEDICAL COMPONENT SPECIALISTS
Reg #: 3011874600
·
FEI: 3011874600
·
Expires 2026
Products
13
Proprietary Names
27
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- MEDICAL COMPONENT SPECIALISTS
- Registration Number
- 3011874600
- FEI Number
- 3011874600
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 42 Williams Way
- City
- Bellingham
- State
- MA
- ZIP
- 02019
- Country
- US
Owner / Operator
- Firm Name
- Medical Component Specialists
- Operator Number
- 10053311
- Address
- 42 Williams way
- City
- Bellingham
- State
- MA
- Postal Code
- 02019
- Country
- US
- Correspondent
- Kevin Rebello
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2022-04-13 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2021-03-11 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2016-11-21 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2016-11-21 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2016-11-21 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2016-11-21 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2016-11-21 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2022-04-13 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2018-11-30 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2021-07-27 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2016-11-22 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2025-01-31 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2026-04-21 |
Proprietary Names
Accelus
DJO
Alctus Spine Pedicle Screw System
Sniper Staple
X010-0178-NT: 500MM K-WIRE BLUNT NITINOL Guide Needle; Pin
X063-0063: 500MM K-WIRE TROCAR Guide Needle; Pin
X079-0043: 90 STYLET, 350MM Guide Needle; Pin
X010-0178: 500MM K-WIRE BLUNT Guide Needle; Pin
X010-0177NT: 500MM K-WIRE NITINOL Guide Needle Pin
X079-0086: 300MM STEINMANN PIN, BLUNT Guide Needle; Pin
X063-0072: 350MM K-WIRE BLUNT Guide Needle; Pin
X063-0073: 500MM K-WIRE BLUNT Guide Needle; Pin
X010-0177: 500MM K-WIRE Guide Needle; Pin
Z079-0057: 300MM STEINMANN PIN, TREADED Guide Needle; Pin
X063-0062: 350MM K-WIRE TROCAR Guide Needle; Pin
X079-0089: EXCHANGE PIN Guide Needle; Pin
Z079-0086: 300MM STEINMANN PIN, BLUNT Guide Needle; Pin
T076-0108: 63 INCH K-WIRE, 500MM, BLUNT Guide Needle; Pin
T076-0103: 63 INCH K-WIRE, 500MM, TROCAR Guide Needle; Pin
X079-0054: 300MM STEINMANN PIN, TROCAR Guide Needle; Pin
N60001000: 62 STYLET, 300 MM Guide Needle; Pin
X079-0057: 300MM STEINMANN PIN, TREADED Guide Needle; Pin
Z079-0054: 300MM STEINMANN PIN, TROCAR Guide Needle; Pin
Medline UNITEs REFLEX Hybrid Nitinol Implant System
AR-8967KT-12
AR-9165K
AR-8967KT
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)