SURGICAL PLANNING ASSOCIATES

FDA Device Registration & Listing · Boston, MA, US · Registration 3008869747

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
3008869747
FEI Number
3008869747
Entity Name
SURGICAL PLANNING ASSOCIATES
City/State/Country
Boston, MA, US
Establishment Address
New England Baptist Hospital, 125 Parker Hill Ave Suite 545, Boston, MA 02120, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Surgical Planning Associates (Owner Number: 10035030)
Owner / Operator Contact Address
New England Baptist Hospital, 125 Parker Hill Ave Suite 545, Boston, MA 02120, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K233315
PMA Number
N/A

All Registered Proprietary Names

HipInsight System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OSF Patient Specific Manual Orthopedic Stereotaxic System Neurology Class 2 882.4560 2021-03-31
SBF Orthopedic Augmented Reality Neurology Class 2 882.4560 2021-03-31
SBF Orthopedic Augmented Reality Neurology Class 2 882.4560 2024-10-24
OSF Patient Specific Manual Orthopedic Stereotaxic System Neurology Class 2 882.4560 2024-10-24

Official Correspondent

Stephen Murphy

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Surgical Planning Associates
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008869747. Last updated year: 2026. Please use registration number 3008869747 when referencing this establishment in official correspondence.
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