federal_register: 95-31047
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 95-31047 | Orthopedic Devices: Classification, Reclassification, and Codification of Pedicle Screw Spinal Systems; Correction | Proposed Rule | The Food and Drug Administration (FDA) is correcting certain statements in the preamble to a proposed rule that appeared in the Federal Register of October 4, 1995 (60 FR 51946). The document proposed to classify certain unclassified preamendments pedicle screw spinal systems into class II (special controls), and to reclassify certain postamendments pedicle screw spinal systems from class III (premarket approval) to class II. The document states further that FDA is issuing for public comment the recommendations of the Orthopedic and Rehabilitation Devices Panel (the Panel) concerning the classification/ reclassification of pedicle screw spinal systems, and the agency's tentative findings on the Panel's recommendations. The document is being corrected to reflect an accurate description of the formation, membership, and activities of the Spinal Implant Manufacturers Group (SIMG), and the Scientific Committee, two separate entities established by the spinal implant manufacturers and medical professional societies to collect and submit to FDA all available valid scientific data on the performance of pedicle screw spinal devices. | 1995-12-21 | 1995 | 12 | https://www.federalregister.gov/documents/1995/12/21/95-31047/orthopedic-devices-classification-reclassification-and-codification-of-pedicle-screw-spinal-systems | https://www.govinfo.gov/content/pkg/FR-1995-12-21/pdf/95-31047.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is correcting certain statements in the preamble to a proposed rule that appeared in the Federal Register of October 4, 1995 (60 FR 51946). The document proposed to classify certain unclassified preamendments... |