FDA Registration
Active
🇺🇸 United States
THE ANSPACH EFFORT, INC.
Reg #: 1045834
·
FEI: 1045834
·
Expires 2026
Products
19
Proprietary Names
30
Establishment Types
4
Classifications
19
Registration Details
- Registration Name
- THE ANSPACH EFFORT, INC.
- Registration Number
- 1045834
- FEI Number
- 1045834
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 4500 RIVERSIDE DR.
- City
- Palm Bch Gdns
- State
- FL
- ZIP
- 33410
- Country
- US
Regulatory Submissions
- 510(k) Number
- K011444
Owner / Operator
- Firm Name
- THE ANSPACH EFFORT, INC.
- Operator Number
- 1045834
- Address
- 4500 Riverside Dr
- City
- Palm Beach Gardens
- State
- FL
- Postal Code
- 33410
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Motor, Drill, Electric | HBC | Class 2 | Neurology | No | 2012-07-06 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2012-07-06 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2024-09-26 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2012-07-06 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2018-07-20 |
| Drill, Bone, Powered | DZI | Class 2 | Dental | No | 2025-08-25 |
| Driver, Wire, And Bone Drill, Manual | DZJ | Class 2 | Dental | No | 2025-08-25 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2012-07-06 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2025-07-23 |
| Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | HSZ | Class 1 | General, Plastic Surgery | No | 2012-07-06 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2003-07-15 |
| Motor, Drill, Pneumatic | HBB | Class 2 | Neurology | No | 2012-07-06 |
| Battery, Replacement, Rechargeable | MOQ | Class 1 | General, Plastic Surgery | No | 2024-09-05 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2014-01-17 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2025-07-23 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2024-09-05 |
| Drills, Burrs, Trephines & Accessories (Compound, Powered) | HBF | Class 2 | Neurology | No | 2009-01-25 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2025-07-23 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2024-09-05 |
Proprietary Names
e12 Electric Instrument System
Anspach Attachments
Anspach Dissection Tools
Anspach eMax Electric Drill System
Anspach eMax 2 Electric Drill System
VELYS(TM)
G1 High Speed Electric System
KINCISE
OCM-G1
Synthes
Drills, Burrs, Trephines & Powered
Anspach Shielded Attachments
EG1
Electric Pen Drive
Anspach MRI Safe Surgical Drill System
Anspach XMax Pneumatic Drill System
Anspach Pneumatic Instrument System Accessories
Anspach BlackMax Pneumatic Drill System
Anspach Irrigation System
TRAY SURGICAL INSTRUMENT
Anspach Helix Dissection Tools
Anspach Speed Reducer
Anspach Compact SpeedReducer
Otologic Attachment and Curved Burrs
SYNTHES AIR PEN DRIVE (APD) SYSTEM
Anspach MicroMax System
eMax 2 Plus System
VELYS
Blade
Irrigation clips
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device