The following data is part of a premarket notification filed by Biopro, Inc. with the FDA for Biopro Memory Staple, Models 18062-18073.
| Device ID | K072298 |
| 510k Number | K072298 |
| Device Name: | BIOPRO MEMORY STAPLE, MODELS 18062-18073 |
| Classification | Staple, Fixation, Bone |
| Applicant | BIOPRO, INC. 17 SEVENTEENTH ST. Port Huron, MI 48060 |
| Contact | David Mrak |
| Correspondent | David Mrak BIOPRO, INC. 17 SEVENTEENTH ST. Port Huron, MI 48060 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-17 |
| Decision Date | 2007-10-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810012485739 | K072298 | 000 |
| 00810012484077 | K072298 | 000 |
| 00810012484084 | K072298 | 000 |
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| M209183120 | K072298 | 000 |
| M209189600 | K072298 | 000 |
| M209152590 | K072298 | 000 |
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| M209195120 | K072298 | 000 |
| M209195130 | K072298 | 000 |
| M209195140 | K072298 | 000 |
| 00841742100777 | K072298 | 000 |