The following data is part of a premarket notification filed by Hand Biomechanics Lab, Inc. with the FDA for Wristjack Orif System, Wristjack Orif System, Non-sterile, Models Cfd-347, Cfd-347-ns.
| Device ID | K033112 |
| 510k Number | K033112 |
| Device Name: | WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | HAND BIOMECHANICS LAB, INC. 77 SCRIPPS DR., SUITE 104 Sacramento, CA 95825 |
| Contact | Timothy R Stallings |
| Correspondent | Timothy R Stallings HAND BIOMECHANICS LAB, INC. 77 SCRIPPS DR., SUITE 104 Sacramento, CA 95825 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-30 |
| Decision Date | 2003-11-05 |
| Summary: | summary |