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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- OSFPatient Specific Manual Orthopedic Stereotaxic System2Product Code
- OJPOrthopedic Computer Controlled Surgical System2Product Code
- OLOOrthopedic Stereotaxic Instrument2Product Code
- ONNIntraoperative Orthopedic Joint Assessment Aid2Product Code
- OSEPatient Specific Manual Navigation System2Product Code
- SBFOrthopedic Augmented Reality2Product Code
- Subpart E—Surgical DevicesCFR Sub-Part
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Orthopedic Augmented Reality
- Page Type
- Product Code
- Definition
- An orthopedic augmented reality device provides visual guidance during orthopedic procedures, where the use of stereotaxic navigation is utilized. Visual guidance is displayed as “augmented reality” stereoscopic images to intraoperatively augment the user’s field of view.
- Physical State
- Display for augmenting information, stereotaxic navigation software, and associated surgical instruments.
- Technical Method
- Visual guidance is shown through augmenting stereoscopic images while allowing view of the patient anatomy. The stereoscopic images are generated based on stereotaxic navigation software, where reference to rigid anatomical structures can be identified relative to patient imaging. This type of display should not include virtual reality, video see-through / pass-through, or holograms.
- Target Area
- Orthopedic
- 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
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
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).