The following data is part of a premarket notification filed by Innervision, Inc. with the FDA for Macmed Paediatric Intramedullary Nail.
| Device ID | K991877 |
| 510k Number | K991877 |
| Device Name: | MACMED PAEDIATRIC INTRAMEDULLARY NAIL |
| Classification | Nail, Fixation, Bone |
| Applicant | INNERVISION, INC. 6258 SHADY GROVE RD. E. Memphis, TN 38120 |
| Contact | Frank M Lewis |
| Correspondent | Frank M Lewis INNERVISION, INC. 6258 SHADY GROVE RD. E. Memphis, TN 38120 |
| Product Code | JDS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-02 |
| Decision Date | 1999-08-06 |