The following data is part of a premarket notification filed by Skeletal Dynamics, Llc with the FDA for Skeletal Dynamics Sterilization Trays.
| Device ID | K102103 |
| 510k Number | K102103 |
| Device Name: | SKELETAL DYNAMICS STERILIZATION TRAYS |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | SKELETAL DYNAMICS, LLC 8905 SW 87 AVENUE, SUITE 201 Miami, FL 33176 |
| Contact | Ana M Escagedo |
| Correspondent | Ana M Escagedo SKELETAL DYNAMICS, LLC 8905 SW 87 AVENUE, SUITE 201 Miami, FL 33176 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-27 |
| Decision Date | 2010-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841506109176 | K102103 | 000 |
| 00841506100463 | K102103 | 000 |
| 00841506100456 | K102103 | 000 |
| 00841506100449 | K102103 | 000 |
| 00841506100432 | K102103 | 000 |
| 00841506100425 | K102103 | 000 |
| 00841506100418 | K102103 | 000 |
| 00841506100401 | K102103 | 000 |
| 00841506100395 | K102103 | 000 |
| 00841506100388 | K102103 | 000 |
| 00841506100371 | K102103 | 000 |
| 00841506131917 | K102103 | 000 |
| 00841506131900 | K102103 | 000 |
| 00841506131894 | K102103 | 000 |
| 00841506131887 | K102103 | 000 |
| 00841506131870 | K102103 | 000 |
| 00841506131689 | K102103 | 000 |
| 00841506100470 | K102103 | 000 |
| 00841506100487 | K102103 | 000 |
| 00841506100494 | K102103 | 000 |
| 00841506100692 | K102103 | 000 |
| 00841506100685 | K102103 | 000 |
| 00841506100678 | K102103 | 000 |
| 00841506100661 | K102103 | 000 |
| 00841506100654 | K102103 | 000 |
| 00841506100647 | K102103 | 000 |
| 00841506100630 | K102103 | 000 |
| 00841506100586 | K102103 | 000 |
| 00841506100579 | K102103 | 000 |
| 00841506100562 | K102103 | 000 |
| 00841506100555 | K102103 | 000 |
| 00841506100548 | K102103 | 000 |
| 00841506100531 | K102103 | 000 |
| 00841506100524 | K102103 | 000 |
| 00841506100517 | K102103 | 000 |
| 00841506100500 | K102103 | 000 |
| 00841506131986 | K102103 | 000 |