The following data is part of a premarket notification filed by Pilling Co. with the FDA for Kambin Spinal Instrument Set.
| Device ID | K853678 |
| 510k Number | K853678 |
| Device Name: | KAMBIN SPINAL INSTRUMENT SET |
| Classification | Instrument, Cutting, Orthopedic |
| Applicant | PILLING CO. 420 DELAWARE DR. Fort Washington, PA 19034 |
| Contact | Leland J Wimer |
| Correspondent | Leland J Wimer PILLING CO. 420 DELAWARE DR. Fort Washington, PA 19034 |
| Product Code | HTZ |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-03 |
| Decision Date | 1985-09-24 |