The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Howmedica(r) Mono-tube(tm) External Fixator System.
| Device ID | K930836 |
| 510k Number | K930836 |
| Device Name: | HOWMEDICA(R) MONO-TUBE(TM) EXTERNAL FIXATOR SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| 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 | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-17 |
| Decision Date | 1995-01-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327083774 | K930836 | 000 |
| 07613327083750 | K930836 | 000 |
| 07613327083743 | K930836 | 000 |
| 07613327083736 | K930836 | 000 |
| 07613327083729 | K930836 | 000 |
| 07613327083705 | K930836 | 000 |
| 07613327088946 | K930836 | 000 |
| 07613327088892 | K930836 | 000 |
| 07613327088878 | K930836 | 000 |