The following data is part of a premarket notification filed by Smith & Nephew, Inc., Orthopaedic Div. with the FDA for Ha Global Taper (gt) Tapered Hip Stem.
| Device ID | K970337 |
| 510k Number | K970337 |
| Device Name: | HA GLOBAL TAPER (GT) TAPERED HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. 1450 E. BROOKS RD. Memphis, TN 38116 |
| Contact | Thomas L Craig |
| Correspondent | Thomas L Craig SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. 1450 E. BROOKS RD. Memphis, TN 38116 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-29 |
| Decision Date | 1997-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010385031 | K970337 | 000 |
| 03596010194619 | K970337 | 000 |
| 03596010194602 | K970337 | 000 |
| 03596010194596 | K970337 | 000 |
| 03596010194589 | K970337 | 000 |
| 03596010194572 | K970337 | 000 |
| 03596010194565 | K970337 | 000 |
| 03596010194558 | K970337 | 000 |
| 03596010194541 | K970337 | 000 |
| 03596010194626 | K970337 | 000 |
| 03596010384935 | K970337 | 000 |
| 03596010385024 | K970337 | 000 |
| 03596010385017 | K970337 | 000 |
| 03596010385000 | K970337 | 000 |
| 03596010384997 | K970337 | 000 |
| 03596010384980 | K970337 | 000 |
| 03596010384973 | K970337 | 000 |
| 03596010384966 | K970337 | 000 |
| 03596010384942 | K970337 | 000 |
| 03596010194534 | K970337 | 000 |