The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker 2s Spinal System.
Device ID | K930009 |
510k Number | K930009 |
Device Name: | STRYKER 2S SPINAL SYSTEM |
Classification | Appliance, Fixation, Spinal Interlaminal |
Applicant | STRYKER CORP. 2 PEASE COURT 59 Route 17, NJ 07401 |
Contact | Bob Koch |
Correspondent | Bob Koch STRYKER CORP. 2 PEASE COURT 59 Route 17, NJ 07401 |
Product Code | KWP |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-04 |
Decision Date | 1994-09-01 |