The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Hoffmann Ii External Fixation System Line Extension Model 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, Hoffmann Ii Ex.
| Device ID | K102885 |
| 510k Number | K102885 |
| Device Name: | HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX |
| Classification | Component, Traction, Invasive |
| Applicant | STRYKER CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Zamir Bar-david |
| Correspondent | Zamir Bar-david STRYKER CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-30 |
| Decision Date | 2011-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327091526 | K102885 | 000 |
| 07613327089158 | K102885 | 000 |
| 07613327079128 | K102885 | 000 |
| 07613327086010 | K102885 | 000 |