Approval for the following modifications:1)the "tombstone" - no part number a)change of indication b)minor grammatical corrections of labeling 2)the physician manual-part number 380-0001-0001-844 a)change of indication b)removed all references to "snap-on electrodes" (obsolete) c)reduced the number of sizes of foam spacers provided from two to one d)increased the number of leads provided from two to three (20" lead added) e)minor grammatical corrections of labeling 3)the patient manual - part number 380-0002-0001-844 a)change of indication b)removed all references to "snap-on electrodes" (obsolete) c)reduced the number of sizes of foam spacers provided from two to one d)increased the number of leads provided from two to three (20" lead added) e)added the section "electrode retainers" (copied from physician manual) f)minor grammatical corrections. The indication change listed above in each section is as follows: removal of the reference to a nine month clinical study time in the approved labels ("a non-union is considered to be established when a minimum of 9 months has elapsed since injury and the fracture site shows no visible progressives signs of healing for a minimum of 3 months - no change in fracture callus") and to insert language as suggested in the fda letter of june 3, 1998 ("a nonunion is considered to be established when the fracture site shows no visible progressive signs of healing"). The device as modified, will be marketed under the trade name orthopak(r) and is indicated for treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, where width of the defect is less than on-half the width of the defect is less than one-half the width of the bone to be treated.
| Device | ORTHOPAK II BONE GROWTH STIMULATOR |
| Classification Name | Stimulator, Bone Growth, Non-invasive |
| Generic Name | Stimulator, Bone Growth, Non-invasive |
| Applicant | EBI, LLC |
| Date Received | 1998-06-18 |
| Decision Date | 1998-07-14 |
| PMA | P850022 |
| Supplement | S011 |
| Product Code | LOF |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | EBI, LLC 399 Jefferson Road parsippany, NJ 07054 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P850022 | | Original Filing |
| S031 |
2022-10-28 |
30-day Notice |
| S030 |
2019-09-10 |
Real-time Process |
| S029 |
2018-03-01 |
30-day Notice |
| S028 |
2016-11-08 |
30-day Notice |
| S027 |
2015-12-17 |
30-day Notice |
| S026 |
2015-10-08 |
30-day Notice |
| S025 |
2015-08-10 |
30-day Notice |
| S024 |
2015-04-24 |
Real-time Process |
| S023 |
2014-08-04 |
30-day Notice |
| S022 |
2014-04-10 |
30-day Notice |
| S021 |
2014-02-24 |
30-day Notice |
| S020 |
2013-08-13 |
Special (immediate Track) |
| S019 | | |
| S018 |
2011-06-13 |
Real-time Process |
| S017 |
2009-09-16 |
Normal 180 Day Track |
| S016 |
2006-02-06 |
Normal 180 Day Track |
| S015 |
2003-09-30 |
Normal 180 Day Track |
| S014 |
2003-04-23 |
Special (immediate Track) |
| S013 |
2001-06-11 |
Normal 180 Day Track |
| S012 |
1999-07-09 |
Real-time Process |
| S011 |
1998-06-18 |
Real-time Process |
| S010 | | |
| S009 |
1997-03-13 |
Panel Track |
| S008 |
1992-10-05 |
Normal 180 Day Track |
| S007 |
1992-09-24 |
Normal 180 Day Track |
| S006 |
1989-08-25 |
Normal 180 Day Track |
| S005 |
1989-01-26 |
Normal 180 Day Track |
| S004 |
1987-08-04 |
Normal 180 Day Track |
| S003 |
1986-11-17 |
Special (immediate Track) |
| S002 | | |
| S001 |
1986-09-16 |
Special (immediate Track) |
NIH GUDID Devices