United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2003_register executive 2010-09-23 article Rules and Regulations D09002ee1c817c224 D09002ee1c817c373 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is classifying the resorbable calcium salt bone void filler device intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a class II special controls guidance entitled "Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA." This action is being undertaken based on new information submitted in a classification proposal from Wright Medical Technology under the Federal Food, Drug, and Cosmetic Act as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. 68 FR 32635 https://www.govinfo.gov/app/details/FR-2003-06-02/03-13592 03-13592 fr02jn03-7 4160-01-S Docket No. 01N-0411 https://www.govinfo.gov/app/details/FR-2003-06-02/03-13592 https://www.govinfo.gov/content/pkg/FR-2003-06-02/html/03-13592.htm https://www.govinfo.gov/content/pkg/FR-2003-06-02/pdf/03-13592.pdf 3 p. 32635 32637 68 FR 32635 Title 21 Part 888 21 CFR Part 888 Orthopedic Devices; Classification for the Resorbable Calcium Salt Bone Void Filler Device; Federal Register Vol. 68, Issue RULE 03-13592 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2003-07-02 Docket No. 01N-0411 4160-01-S 03-13592 Final rule.

The Food and Drug Administration (FDA) is classifying the resorbable calcium salt bone void filler device intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a class II special controls guidance entitled "Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA." This action is being undertaken based on new information submitted in a classification proposal from Wright Medical Technology under the Federal Food, Drug, and Cosmetic Act as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997.

This rule is effective July 2, 2003 Nadine Y. Sloan, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1296. Medical devices: Orthopedic devices Resorbable calcium salt bone void filler device; classification, Vol. 68, no. 105 Office of the Federal Register, National Archives and Records Administration 2003-06-02 continuing daily deposited born digital 346 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2003-06-02 P0b002ee18099ec6f 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr02jn03 https://www.govinfo.gov/app/details/FR-2003-06-02 https://www.govinfo.gov/content/pkg/FR-2003-06-02/pdf/FR-2003-06-02.pdf https://www.govinfo.gov/content/pkg/FR-2003-06-02/xml/FR-2003-06-02.xml fdlp 32623 32954 DGPO 2010-09-23 2024-06-07 FR-2003-06-02 machine generated eng FR FR-2003-06-02 68 105