The following data is part of a premarket notification filed by Stryker Orthopaedics with the FDA for Restoration Anatomic Shell.
| Device ID | K142462 |
| 510k Number | K142462 |
| Device Name: | Restoration Anatomic Shell |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Denise Daugert |
| Correspondent | Denise Daugert STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-02 |
| Decision Date | 2014-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327012651 | K142462 | 000 |
| 07613327012484 | K142462 | 000 |
| 07613327012477 | K142462 | 000 |
| 07613327012460 | K142462 | 000 |
| 07613327012453 | K142462 | 000 |
| 07613327012446 | K142462 | 000 |
| 07613327012439 | K142462 | 000 |
| 07613327012422 | K142462 | 000 |
| 07613327012415 | K142462 | 000 |
| 07613327012408 | K142462 | 000 |
| 07613327012385 | K142462 | 000 |
| 07613327012361 | K142462 | 000 |
| 07613327012354 | K142462 | 000 |
| 07613327012491 | K142462 | 000 |
| 07613327012514 | K142462 | 000 |
| 07613327012637 | K142462 | 000 |
| 07613327012620 | K142462 | 000 |
| 07613327012613 | K142462 | 000 |
| 07613327012606 | K142462 | 000 |
| 07613327012590 | K142462 | 000 |
| 07613327012583 | K142462 | 000 |
| 07613327012576 | K142462 | 000 |
| 07613327012569 | K142462 | 000 |
| 07613327012552 | K142462 | 000 |
| 07613327012545 | K142462 | 000 |
| 07613327012538 | K142462 | 000 |
| 07613327012521 | K142462 | 000 |
| 07613327012347 | K142462 | 000 |