The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Concept Cannulated Intereference Screw.
| Device ID | K933352 |
| 510k Number | K933352 |
| Device Name: | CONCEPT CANNULATED INTEREFERENCE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 |
| Contact | Martha C Miller |
| Correspondent | Martha C Miller LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-09 |
| Decision Date | 1994-02-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854033637 | K933352 | 000 |
| 20845854015237 | K933352 | 000 |
| 20845854015084 | K933352 | 000 |
| 20845854014957 | K933352 | 000 |
| 20845854014797 | K933352 | 000 |
| 20845854014636 | K933352 | 000 |
| 10845854016442 | K933352 | 000 |
| 10845854016183 | K933352 | 000 |
| 10845854016121 | K933352 | 000 |
| 10845854015797 | K933352 | 000 |
| 10845854016435 | K933352 | 000 |
| 10845854016329 | K933352 | 000 |
| 10845854015933 | K933352 | 000 |
| 10845854015827 | K933352 | 000 |
| 10845854015803 | K933352 | 000 |
| 20845854015305 | K933352 | 000 |
| 20845854015343 | K933352 | 000 |
| 20845854033620 | K933352 | 000 |
| 20845854033613 | K933352 | 000 |
| 20845854033606 | K933352 | 000 |
| 20845854033590 | K933352 | 000 |
| 20845854033583 | K933352 | 000 |
| 20845854033576 | K933352 | 000 |
| 20845854033569 | K933352 | 000 |
| 20845854033552 | K933352 | 000 |
| 20845854033545 | K933352 | 000 |
| 20845854029388 | K933352 | 000 |
| 20845854029371 | K933352 | 000 |
| 20845854016463 | K933352 | 000 |
| 20845854016203 | K933352 | 000 |
| 20845854015497 | K933352 | 000 |
| 10845854015605 | K933352 | 000 |