FDA 510(k) Applications Submitted by Donald W. Guthner
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K250382 |
02/11/2025 |
Freedom Total Knee System (All-poly Tibial Plate) |
Maxx Orthopedics, Inc. |
| K050462 |
02/23/2005 |
SBI HAND FIXATION SYSTEM (TM) |
SMALL BONE INNOVATIONS LLC |
| K070761 |
03/20/2007 |
SANATMETAL NAILS AND PINS |
SANATMETAL MFR. OF ORTHOPAEDIC/TRAUMATOLOGIC PROD. |
| K051605 |
06/16/2005 |
SBI K-WIRES |
SMALL BONE INNOVATIONS, LLC |
| K051747 |
06/29/2005 |
SBI WRISTFIT |
SMALL BONE INNOVATIONS, LLC |
| K072370 |
08/23/2007 |
SURGICRAFT SURGICAL MESH SYSTEM |
SURGICRAFT LTD. |
| K052576 |
09/19/2005 |
SBI AUTOFIX |
SMALL BONE INNOVATIONS, LLC |
| K243277 |
10/16/2024 |
Freedom« Medial Congruent Liner |
Maxx Orthopedics, Inc. |
| K083798 |
12/22/2008 |
IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF |
MEDICREA TECHNOLOGIES |
| K080447 |
02/19/2008 |
SURGICRAFT SCREW FIXATION SYSTEM |
SURGICRAFT LTD. |
| K100516 |
02/23/2010 |
ANYPLUS PEEK CAGES |
GS MEDICAL CO., LTD. |
| K091207 |
04/24/2009 |
SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE |
SURGICRAFT LTD. |
| K111354 |
05/13/2011 |
GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF) |
GS MEDICAL CO., LTD. |
| K131612 |
06/03/2013 |
ANYPLUS; ALIF PEEK CAGES, PLIF PEEK CAGES, T-PLIF PEEK CAGES, TLIF PEEK CAGES |
GS MEDICAL CO., LTD. |
| K072415 |
08/28/2007 |
STALIF (TM) C |
SURGICRAFT LTD. |
| K112607 |
09/07/2011 |
SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S.(TM) POLYAXIAL PEDICLE ... |
SPINEVISION, S.A. |
| K073109 |
11/02/2007 |
STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM |
SURGICRAFT LTD. |
| K210595 |
03/01/2021 |
SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers |
Camber Spine Technologies, LLC |
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