The following data is part of a premarket notification filed by Synthes Spine Co.lp with the FDA for Synfix-lr Spacer.
| Device ID | K072253 |
| 510k Number | K072253 |
| Device Name: | SYNFIX-LR SPACER |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| 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 | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-14 |
| Decision Date | 2007-10-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H981048022130 | K072253 | 000 |
| H98108802019S0 | K072253 | 000 |
| H98108802018S0 | K072253 | 000 |
| H98108802017S0 | K072253 | 000 |
| H98108802016S0 | K072253 | 000 |
| H981038024310 | K072253 | 000 |
| H981SD038024340 | K072253 | 000 |
| H981SD038024310 | K072253 | 000 |
| H981SD038023310 | K072253 | 000 |