The following data is part of a premarket notification filed by Ace Orthopedic Manufacturing Co. with the FDA for Bone Clamp, Ace External.
| Device ID | K781839 |
| 510k Number | K781839 |
| Device Name: | BONE CLAMP, ACE EXTERNAL |
| Classification | Component, Traction, Invasive |
| Applicant | ACE ORTHOPEDIC MANUFACTURING CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-10-27 |
| Decision Date | 1978-11-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868070303 | K781839 | 000 |