The following data is part of a premarket notification filed by Synthes Spine Co.lp with the FDA for Synthes Zero-p.
| Device ID | K072981 |
| 510k Number | K072981 |
| Device Name: | SYNTHES ZERO-P |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Susan Lewandowski |
| Correspondent | Susan Lewandowski SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-23 |
| Decision Date | 2008-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98104617139S0 | K072981 | 000 |
| H98104617119S0 | K072981 | 000 |
| H98104617118S0 | K072981 | 000 |
| H98104617117S0 | K072981 | 000 |
| H98104617116S0 | K072981 | 000 |
| H98104617115S0 | K072981 | 000 |
| H98104617112S0 | K072981 | 000 |
| H98104617111S0 | K072981 | 000 |
| H98104617110S0 | K072981 | 000 |
| H981046178160 | K072981 | 000 |
| H981046178140 | K072981 | 000 |
| H981046178120 | K072981 | 000 |
| H981SD036179010 | K072981 | 000 |
| H98104617120S0 | K072981 | 000 |
| H98104617121S0 | K072981 | 000 |
| H98104617122S0 | K072981 | 000 |
| H98104617138S0 | K072981 | 000 |
| H98104617137S0 | K072981 | 000 |
| H98104617136S0 | K072981 | 000 |
| H98104617135S0 | K072981 | 000 |
| H98104617132S0 | K072981 | 000 |
| H98104617131S0 | K072981 | 000 |
| H98104617130S0 | K072981 | 000 |
| H98104617129S0 | K072981 | 000 |
| H98104617128S0 | K072981 | 000 |
| H98104617127S0 | K072981 | 000 |
| H98104617126S0 | K072981 | 000 |
| H98104617125S0 | K072981 | 000 |
| H981SD036179000 | K072981 | 000 |