The following data is part of a premarket notification filed by Macropore Biosurgery, Inc. with the FDA for Macroporedx Distractor System.
| Device ID | K000992 |
| 510k Number | K000992 |
| Device Name: | MACROPOREDX DISTRACTOR SYSTEM |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST. San Diego, CA 92121 |
| Contact | Kenneth K Kleinhenz |
| Correspondent | Kenneth K Kleinhenz MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST. San Diego, CA 92121 |
| Product Code | MQN |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-28 |
| Decision Date | 2000-06-26 |