The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Stableloc Ii External Fixator.
| Device ID | K965029 |
| 510k Number | K965029 |
| Device Name: | STABLELOC II EXTERNAL FIXATOR |
| Classification | Component, Traction, Invasive |
| Applicant | ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
| Contact | Shari L Jeffers |
| Correspondent | Shari L Jeffers ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-17 |
| Decision Date | 1997-02-19 |
| Summary: | summary |