Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- PDQNeurosurgical Nerve Locator2Product Code
- HRWDynamometer, Nonpowered1Product Code
- KQWGoniometer, Nonpowered1Product Code
- KQXGoniometer, Ac-Powered1Product Code
- K011827ORTELIUS 8001Cleared 510(K)
- K971079INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE1Cleared 510(K)
- K9623773D-SPINE1Cleared 510(K)
- K961212SPINAL TOUCH1Cleared 510(K)
- K954647INCLINOMETER1Cleared 510(K)
- K943929DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS)1Cleared 510(K)
- K945630LARGE MUSCLE STRENGTH GAUGE1Cleared 510(K)
- K943898SAUNDERS ELECTRONIC INCLINOMETER1Cleared 510(K)
- K940812INSIGHT ELECTRONIC ALIGNMENT INDICATOR1Cleared 510(K)
- K925225THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK1Cleared 510(K)
- Show All 33 Submissions
- LBBDynamometer, Ac-Powered2Product Code
- NKIGoniometer With Electrodes2Product Code
- QWPOptical Neurosurgical Nerve Locator2Product Code
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
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- UnknownReview Panel
ORTELIUS 800
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K011827
- 510(k) Type
- Traditional
- Applicant
- ORTHOSCAN LTD.
- Country
- Israel
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/28/2001
- Days to Decision
- 77 days
- Submission Type
- Summary