The following data is part of a premarket notification filed by Innovasive Devices, Inc. with the FDA for Bio-interference Screw.
| Device ID | K990454 |
| 510k Number | K990454 |
| Device Name: | BIO-INTERFERENCE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | INNOVASIVE DEVICES, INC. 734 FOREST ST. Marlborough, MA 01752 |
| Contact | Kathleen Morahan |
| Correspondent | Kathleen Morahan INNOVASIVE DEVICES, INC. 734 FOREST ST. Marlborough, MA 01752 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-12 |
| Decision Date | 1999-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705013005 | K990454 | 000 |
| 10886705012992 | K990454 | 000 |
| 10886705012985 | K990454 | 000 |
| 10886705012978 | K990454 | 000 |
| 10886705012961 | K990454 | 000 |
| 10886705012954 | K990454 | 000 |
| 10886705012947 | K990454 | 000 |
| 10886705012930 | K990454 | 000 |