FDA Registration Active 🇺🇸 United States

3105001000 HipMap Femoroacetabular Impingement Analysis

Reg #: 2936485 · FEI: 2936485 · Expires 2025
Products
1
Proprietary Names
3
Establishment Types
2
Classifications
1

Registration Details

Registration Name
STRYKER ENDOSCOPY
Registration Number
2936485
FEI Number
2936485
Status
Active
Expiry Year
2025
Initial Importer
No
Address
5900 Optical Ct
City
SAN JOSE
State
CA
ZIP
95138
Country
US

Regulatory Submissions

510(k) Number
K230045

Owner / Operator

Firm Name
STRYKER CORP.
Operator Number
1811755
Address
4100 East Milham Ave.
City
Kalamazoo
State
MI
Postal Code
49001
Country
US

Products

Device Name Product Code
Automated Radiological Image Processing Software QIH

Proprietary Names

3105001000 HipMap Femoroacetabular Impingement Analysis 01030300 HipCheck Software 01030100 HipCheck

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device