The following data is part of a premarket notification filed by Stryker Spine with the FDA for Thor Anterior Plating System.
Device ID | K080773 |
510k Number | K080773 |
Device Name: | THOR ANTERIOR PLATING SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
Contact | Curtis Truesdale |
Correspondent | Curtis Truesdale STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-03-19 |
Decision Date | 2008-06-09 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07613327067453 | K080773 | 000 |
07613327067316 | K080773 | 000 |
07613327067323 | K080773 | 000 |
07613327067330 | K080773 | 000 |
07613327067347 | K080773 | 000 |
07613327067354 | K080773 | 000 |
07613327067361 | K080773 | 000 |
07613327067378 | K080773 | 000 |
07613327067385 | K080773 | 000 |
07613327067392 | K080773 | 000 |
07613327067408 | K080773 | 000 |
07613327067415 | K080773 | 000 |
07613327067422 | K080773 | 000 |
07613327067439 | K080773 | 000 |
07613327067446 | K080773 | 000 |
07613327067309 | K080773 | 000 |