The following data is part of a premarket notification filed by Precision Surgery Ltd. with the FDA for Fixed, Variable & Corpectomy Cervical Plate System.
| Device ID | K073708 |
| 510k Number | K073708 |
| Device Name: | FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | PRECISION SURGERY LTD. 8202 SHERMAN ROAD Chesterland, OH 44026 -2141 |
| Contact | Karen E Warden |
| Correspondent | Karen E Warden PRECISION SURGERY LTD. 8202 SHERMAN ROAD Chesterland, OH 44026 -2141 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-31 |
| Decision Date | 2008-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M739ST16018 | K073708 | 000 |
| M739CP30470 | K073708 | 000 |
| M739CP30110 | K073708 | 000 |
| M739CP30106 | K073708 | 000 |
| M739CP30102 | K073708 | 000 |
| M739CP30090 | K073708 | 000 |
| M739CP30086 | K073708 | 000 |
| M739CP30082 | K073708 | 000 |
| M739CP30078 | K073708 | 000 |
| M739CP30074 | K073708 | 000 |
| M739CP30070 | K073708 | 000 |
| M739CP30067 | K073708 | 000 |
| M739CP30064 | K073708 | 000 |
| M739CP30061 | K073708 | 000 |
| M739CS06312 | K073708 | 000 |
| M739CS06314 | K073708 | 000 |
| M739ST16016 | K073708 | 000 |
| M739ST16014 | K073708 | 000 |
| M739ST16012 | K073708 | 000 |
| M739ST06018 | K073708 | 000 |
| M739ST06016 | K073708 | 000 |
| M739ST06014 | K073708 | 000 |
| M739ST06012 | K073708 | 000 |
| M739CS16318 | K073708 | 000 |
| M739CS16316 | K073708 | 000 |
| M739CS16314 | K073708 | 000 |
| M739CS16312 | K073708 | 000 |
| M739CS06318 | K073708 | 000 |
| M739CS06316 | K073708 | 000 |
| M739CP30020 | K073708 | 000 |