The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Surgical Instruments For Use W/zimmer.
| Device ID | K811675 |
| 510k Number | K811675 |
| Device Name: | SURGICAL INSTRUMENTS FOR USE W/ZIMMER |
| Classification | Arthroscope |
| Applicant | ZIMMER, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-15 |
| Decision Date | 1981-06-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30845854038363 | K811675 | 000 |
| 30845854024724 | K811675 | 000 |