THE ANSPACH EFFORT, INC.

FDA Device Registration & Listing · Palm Bch Gdns, FL, US · Registration 1045834

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1045834
FEI Number
1045834
Entity Name
THE ANSPACH EFFORT, INC.
City/State/Country
Palm Bch Gdns, FL, US
Establishment Address
4500 RIVERSIDE DR., Palm Bch Gdns, FL 33410, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
THE ANSPACH EFFORT, INC. (Owner Number: 1045834)
Owner / Operator Contact Address
4500 Riverside Dr, Palm Beach Gardens, FL 33410, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K965080
PMA Number
N/A

All Registered 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 Anspach Dissection Tools VELYS(TM) KINCISE OCM-G1 VELYS(TM) Synthes Drills, Burrs, Trephines & Powered Anspach Shielded Attachments EG1™ Electric Pen Drive Synthes 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 KINCISE Otologic Attachment and Curved Burrs Synthes SYNTHES AIR PEN DRIVE (APD) SYSTEM Anspach MicroMax System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HBC Motor, Drill, Electric Neurology Class 2 882.4360 2012-07-06
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2012-07-06
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-09-26
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2014-01-17
HBC Motor, Drill, Electric Neurology Class 2 882.4360 2014-01-17
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2012-07-06
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-09-26
GEY Motor, Surgical Instrument, Ac-Powered General, Plastic Surgery Class 1 878.4820 2018-07-20
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2018-04-03
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-09-26
DZI Drill, Bone, Powered Dental Class 2 872.4120 2025-08-25
DZJ Driver, Wire, And Bone Drill, Manual Dental Class 2 872.4120 2025-08-25
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2007-11-28
GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4820 2012-07-06
HBC Motor, Drill, Electric Neurology Class 2 882.4360 2022-05-31
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2022-05-31
DZI Drill, Bone, Powered Dental Class 2 872.4120 2025-07-23
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2025-07-23
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2025-07-23
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2025-07-23
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2012-07-06
HBC Motor, Drill, Electric Neurology Class 2 882.4360 2012-07-06
HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2012-07-06
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2012-01-13
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2003-07-15
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2019-07-30
HBB Motor, Drill, Pneumatic Neurology Class 2 882.4370 2012-07-06
MOQ Battery, Replacement, Rechargeable General, Plastic Surgery Class 1 878.4820 2024-09-05
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2014-01-17
EQJ Bur, Ear, Nose And Throat Ear, Nose, Throat Class 1 874.4140 2014-01-17
HTW Bit, Drill Orthopedic Class 1 888.4540 2025-07-23
HBB Motor, Drill, Pneumatic Neurology Class 2 882.4370 2025-07-23
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2012-07-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

THE ANSPACH EFFORT, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3025110439 DePuy Synthes West Palm Beach West Palm Beach, FL, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K964548 Linvatec Corp. APEX UNIVERSAL DRIVE SYSTEM 1997-01-17
K260601 Blue Belt Technologies, Inc. REAL INTELLIGENCE™ CORI™ 2026-03-26
K905383 Micro Surgical Instruments Corp. 2710-000 OSCILLATING SAW, GENERAL ASSEMBLY 1991-06-18
K913369 Micro Surgical Instruments Corp. MICRO-AIRE MODEL 2060 1991-11-01
K881095 CooperVision, Inc. KOI(TM) INSTRUMENT TRAYS 1988-04-06

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-2024 Blue Belt Technologies, Inc 2
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0036-2010 Alphatec Spine, Inc. 1
ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
Z-0026-2026 Aesculap AG Am Aesculap-Platz 1 Tuttlingen Germany 2
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Z-0027-2026 Aesculap AG Am Aesculap-Platz 1 Tuttlingen Germany 2
AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1045834. Last updated year: 2026. Please use registration number 1045834 when referencing this establishment in official correspondence.
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