The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Smf Hip Stem.
Device ID | K123012 |
510k Number | K123012 |
Device Name: | SMITH & NEPHEW SMF HIP STEM |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Contact | Natalie P Williams |
Correspondent | Natalie P Williams SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Product Code | LPH |
CFR Regulation Number | 888.3358 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-09-28 |
Decision Date | 2012-10-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00885556168516 | K123012 | 000 |
00885556159149 | K123012 | 000 |
00885556159194 | K123012 | 000 |
00885556159248 | K123012 | 000 |
00885556159293 | K123012 | 000 |
00885556159347 | K123012 | 000 |
00885556159392 | K123012 | 000 |
00885556159446 | K123012 | 000 |
00885556159491 | K123012 | 000 |
00885556159545 | K123012 | 000 |
00885556159590 | K123012 | 000 |
00885556168165 | K123012 | 000 |
00885556168219 | K123012 | 000 |
00885556168264 | K123012 | 000 |
00885556168318 | K123012 | 000 |
00885556168417 | K123012 | 000 |
00885556168462 | K123012 | 000 |
00885556159095 | K123012 | 000 |