The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Hoffmann Ii External Fixation System.
| Device ID | K952730 |
| 510k Number | K952730 |
| Device Name: | HOFFMANN II EXTERNAL FIXATION SYSTEM |
| Classification | Component, Traction, Invasive |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Mary C Spicer |
| Correspondent | Mary C Spicer HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-15 |
| Decision Date | 1995-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327092660 | K952730 | 000 |
| 07613327079371 | K952730 | 000 |
| 07613327079340 | K952730 | 000 |
| 07613327079319 | K952730 | 000 |
| 07613327079289 | K952730 | 000 |
| 07613327079258 | K952730 | 000 |
| 07613327072884 | K952730 | 000 |
| 07613327072778 | K952730 | 000 |
| 07613327010572 | K952730 | 000 |
| 07613327079425 | K952730 | 000 |
| 07613327079432 | K952730 | 000 |
| 07613327079463 | K952730 | 000 |
| 07613327092639 | K952730 | 000 |
| 07613327092608 | K952730 | 000 |
| 07613327091496 | K952730 | 000 |
| 07613327091441 | K952730 | 000 |
| 07613327089141 | K952730 | 000 |
| 07613327088151 | K952730 | 000 |
| 07613327079494 | K952730 | 000 |
| 07613327079487 | K952730 | 000 |
| 07613327010565 | K952730 | 000 |