Recognition List Number: 030 Publication Date: 01/15/2013
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 11-251: ASTM F2554-10, Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems. (Orthopaedics)
Date of Standard: 2010. |
| Address of Standards Organization: |
| ASTM International (ASTM) |
| 100 Barr Harbor Drive |
| West Conshohocken, PA 19428-2959 |
| |
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) |
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| Devices Affected: |
| Stereotactic, surgical navigation and robotic positioning systems |
|
| Processes Affected: |
| 510(k), PMA, IDE, HDE, de novo |
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| Type of Standard: |
| National |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §882.4560 |
Neurological Stereotaxic Instrument |
Class 2 |
HAW |
| §882.4560 |
Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri |
Class 2 |
ORR |
| §882.4560 |
Orthopedic Stereotaxic Instrument |
Class 2 |
OLO |
| §882.4560 |
Patient Specific Manual Orthopedic Stereotaxic System |
Class 2 |
OSF |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contact: |
| Dwight Yen |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1432 |
| Silver Spring MD 20993 |
| 301/796-6401 |
| Email: dwight.yen@fda.hhs.gov |
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