The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Explorer To System.
| Device ID | K212540 |
| 510k Number | K212540 |
| Device Name: | Explorer TO System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 |
| Contact | Aly Alvarez |
| Correspondent | Aly Alvarez SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-12 |
| Decision Date | 2021-09-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981289560 | K212540 | 000 |
| 10889981206406 | K212540 | 000 |
| 10889981275860 | K212540 | 000 |
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| 10889981207021 | K212540 | 000 |
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| 10889981206895 | K212540 | 000 |
| 10889981206871 | K212540 | 000 |
| 10889981206857 | K212540 | 000 |
| 10889981206840 | K212540 | 000 |
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| 10889981206413 | K212540 | 000 |
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| 10889981289300 | K212540 | 000 |
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| 10889981206628 | K212540 | 000 |
| 10889981206611 | K212540 | 000 |
| 10889981206598 | K212540 | 000 |
| 10889981206574 | K212540 | 000 |
| 10889981206536 | K212540 | 000 |
| 10889981206512 | K212540 | 000 |
| 10889981206451 | K212540 | 000 |
| 10889981206444 | K212540 | 000 |
| 10889981206437 | K212540 | 000 |
| 10889981206635 | K212540 | 000 |