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 |
H981048022110 | K072253 | 000 |
H981048022120 | K072253 | 000 |
H981SD038023310 | K072253 | 000 |
H981SD038024310 | K072253 | 000 |
H981SD038024340 | K072253 | 000 |
H981038024310 | K072253 | 000 |
H98108802016S0 | K072253 | 000 |
H98108802017S0 | K072253 | 000 |
H98108802018S0 | K072253 | 000 |
H98108802019S0 | K072253 | 000 |
H981048022100 | K072253 | 000 |