FDA device listing
3.0MM DRILL BIT, LONG,Bone Tap,Centerpiece Plate Fixation System,C-STEM AMT HO NECK SEGMENT- SZ 0/1,C-STEM AMT HO NECK…
FDA device listing 1320845491 · Paragon Medical
Key facts
| Proprietary names | 3.0MM DRILL BIT, LONG,Bone Tap,Centerpiece Plate Fixation System,C-STEM AMT HO NECK SEGMENT- SZ 0/1,C-STEM AMT HO NECK SEGMENT- SZ2/3,C-STEM AMT HO NECK SEGMENT- SZ4/5,C-STEM AMT STD NECK SEGMENT- SZ0/1,C-STEM AMT STD NECK SEGMENT- SZ2/3,C-STEM AMT STD NECK SEGMENT- SZ6/7,C-STEM AMT SZ 2A NK SEGMENT,C-STEM AMT SZ 3A NK SEGMENT,Depth Gauge 0-110mm For Screws ø2.7/3.5/4.0,Depth Gauge 0-120mm,Depth… |
|---|---|
| Owner/operator | Paragon Medical |
| Owner/operator number | 9011072 |
| Product codes | LXH |
| Device names | LXH - Orthopedic Manual Surgical Instrument |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | AMETEK Poland sp. z o.o., Paragon Medical Device (Changzhou) Co., Ltd., Paragon Medical Inc., PARAGON MEDICAL, INC. |
| Establishment registrations | 1834331, 1835831, 1000517406, 3007539489, 3009141957 |
| FEI numbers | 1000306340, 1000517406, 3001814066, 3007539489, 3009141957 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database