Last synced on 25 April 2025 at 11:05 pm

Patient Specific Manual Orthopedic Stereotaxic System

Page Type
Product Code
Definition
Intended for defining orthopedic acetabular implant alignment relative to a patient's anatomy.
Physical State
Manual instrument and auxiliary software.
Technical Method
Pre-operative imagery, such as CT or radiographs, is used to establish a correlation between the patient's AP plane and the instrument¿s plane.
Target Area
Acetabulum
Regulation Medical Specialty
Neurology
Review Panel
Orthopedic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.4560
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.4560 Stereotaxic instrument

§ 882.4560 Stereotaxic instrument.

(a) Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

(b) Classification. Class II (performance standards).

Patient Specific Manual Orthopedic Stereotaxic System

Page Type
Product Code
Definition
Intended for defining orthopedic acetabular implant alignment relative to a patient's anatomy.
Physical State
Manual instrument and auxiliary software.
Technical Method
Pre-operative imagery, such as CT or radiographs, is used to establish a correlation between the patient's AP plane and the instrument¿s plane.
Target Area
Acetabulum
Regulation Medical Specialty
Neurology
Review Panel
Orthopedic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.4560
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.4560 Stereotaxic instrument

§ 882.4560 Stereotaxic instrument.

(a) Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

(b) Classification. Class II (performance standards).