The following data is part of a premarket notification filed by Kiscomedica S.a. with the FDA for L-varlock.
| Device ID | K080537 |
| 510k Number | K080537 |
| Device Name: | L-VARLOCK |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | KISCOMEDICA S.A. 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb KISCOMEDICA S.A. 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-27 |
| Decision Date | 2008-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850011324110 | K080537 | 000 |
| 00850011324004 | K080537 | 000 |
| 00850011324134 | K080537 | 000 |
| 00850011324165 | K080537 | 000 |
| 00850011324158 | K080537 | 000 |