The following data is part of a premarket notification filed by Ace Orthopedic Manufacturing Co. with the FDA for Ace Unilateral Fixator Ii.
| Device ID | K936045 |
| 510k Number | K936045 |
| Device Name: | ACE UNILATERAL FIXATOR II |
| Classification | Component, Traction, Invasive |
| Applicant | ACE ORTHOPEDIC MANUFACTURING CO. 14105 SOUTH AVALON BLVD. Los Angeles, CA 90061 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen ACE ORTHOPEDIC MANUFACTURING CO. 14105 SOUTH AVALON BLVD. Los Angeles, CA 90061 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-20 |
| Decision Date | 1994-02-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868001635 | K936045 | 000 |
| 00887868001628 | K936045 | 000 |
| 00887868070297 | K936045 | 000 |
| 00887868070280 | K936045 | 000 |