The following data is part of a premarket notification filed by Ace Medical Co. with the FDA for Reverse Cutting Cannulated Cancellous Bone Screw.
| Device ID | K892214 |
| 510k Number | K892214 |
| Device Name: | REVERSE CUTTING CANNULATED CANCELLOUS BONE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | ACE MEDICAL CO. DAVID W. SCHLERF 921 CALLE VERDE Martinez, CA 94553 |
| Contact | Co, Inc. |
| Correspondent | Co, Inc. ACE MEDICAL CO. DAVID W. SCHLERF 921 CALLE VERDE Martinez, CA 94553 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-03 |
| Decision Date | 1989-06-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868010040 | K892214 | 000 |
| 00887868006340 | K892214 | 000 |
| 00887868006357 | K892214 | 000 |
| 00887868006364 | K892214 | 000 |
| 00887868006371 | K892214 | 000 |
| 00887868006388 | K892214 | 000 |
| 00887868006395 | K892214 | 000 |
| 00887868006401 | K892214 | 000 |
| 00887868006418 | K892214 | 000 |
| 00887868006425 | K892214 | 000 |
| 00887868006432 | K892214 | 000 |
| 00887868006449 | K892214 | 000 |
| 00887868006456 | K892214 | 000 |
| 00887868006463 | K892214 | 000 |
| 00887868010002 | K892214 | 000 |
| 00887868010019 | K892214 | 000 |
| 00887868010026 | K892214 | 000 |
| 00887868010033 | K892214 | 000 |
| 00887868006333 | K892214 | 000 |