The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Intramedullary Compression Arthrodesis (ica) Nail.
| Device ID | K952923 |
| 510k Number | K952923 |
| Device Name: | INTRAMEDULLARY COMPRESSION ARTHRODESIS (ICA) NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Margaret F Crowe |
| Correspondent | Margaret F Crowe HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-26 |
| Decision Date | 1995-09-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327050103 | K952923 | 000 |
| 07613327045116 | K952923 | 000 |
| 07613327045093 | K952923 | 000 |