The following data is part of a premarket notification filed by Howmedica, Inc. with the FDA for Howmedica Humeral Intercalary System.
| Device ID | K984202 |
| 510k Number | K984202 |
| Device Name: | HOWMEDICA HUMERAL INTERCALARY SYSTEM |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Frank Maas |
| Correspondent | Frank Maas HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-24 |
| Decision Date | 1999-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327141337 | K984202 | 000 |
| 07613327049053 | K984202 | 000 |
| 07613327049077 | K984202 | 000 |
| 07613327049084 | K984202 | 000 |
| 07613327049091 | K984202 | 000 |
| 07613327049107 | K984202 | 000 |
| 07613327049114 | K984202 | 000 |
| 07613327049138 | K984202 | 000 |
| 07613327049183 | K984202 | 000 |
| 07613327048742 | K984202 | 000 |