The following data is part of a premarket notification filed by Hd Lifesciences Llc with the FDA for Hd Lifesciences Cervical Ibfd System.
| Device ID | K180364 |
| 510k Number | K180364 |
| Device Name: | HD LifeSciences Cervical IBFD System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | HD LifeSciences LLC 38 Montvale Ave Ste 380 Stoneham, MA 02180 |
| Contact | John Sullivan |
| Correspondent | John Sullivan HD LifeSciences LLC 38 Montvale Ave Ste 380 Stoneham, MA 02180 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-12 |
| Decision Date | 2018-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817493021500 | K180364 | 000 |
| 00817493026215 | K180364 | 000 |
| 00817493026222 | K180364 | 000 |
| 00817493026239 | K180364 | 000 |
| 00817493026246 | K180364 | 000 |
| 00817493026253 | K180364 | 000 |
| 00817493026260 | K180364 | 000 |
| 00817493026277 | K180364 | 000 |
| 00817493026284 | K180364 | 000 |
| 00817493026208 | K180364 | 000 |
| 00817493026192 | K180364 | 000 |
| 00817493026185 | K180364 | 000 |
| 00817493021517 | K180364 | 000 |
| 00817493021524 | K180364 | 000 |
| 00817493021531 | K180364 | 000 |
| 00817493021548 | K180364 | 000 |
| 00817493021555 | K180364 | 000 |
| 00817493021562 | K180364 | 000 |
| 00817493021579 | K180364 | 000 |
| 00817493026178 | K180364 | 000 |
| 00817493026291 | K180364 | 000 |
| 00817493026307 | K180364 | 000 |
| 00817493021111 | K180364 | 000 |
| 00817493021128 | K180364 | 000 |
| 00817493021135 | K180364 | 000 |
| 00817493021142 | K180364 | 000 |
| 00817493021159 | K180364 | 000 |
| 00817493021166 | K180364 | 000 |
| 00817493021173 | K180364 | 000 |
| 00817493021180 | K180364 | 000 |
| 00817493021104 | K180364 | 000 |
| 00817493021050 | K180364 | 000 |
| 00817493020947 | K180364 | 000 |
| 00817493026314 | K180364 | 000 |
| 00817493026321 | K180364 | 000 |
| 00817493020886 | K180364 | 000 |
| 00817493020893 | K180364 | 000 |
| 00817493020909 | K180364 | 000 |
| 00817493020916 | K180364 | 000 |
| 00817493020923 | K180364 | 000 |
| 00817493020930 | K180364 | 000 |
| 00817493021197 | K180364 | 000 |