The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Dall Miles Broad Bone Plate.
| Device ID | K922525 |
| 510k Number | K922525 |
| Device Name: | DALL MILES BROAD BONE PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Robert E Smith |
| Correspondent | Robert E Smith HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-28 |
| Decision Date | 1992-09-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327036657 | K922525 | 000 |
| 07613327036640 | K922525 | 000 |
| 07613327036633 | K922525 | 000 |
| 07613327036626 | K922525 | 000 |