The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Modification Of Encore Linear Porous Coated Hip.
| Device ID | K991325 |
| 510k Number | K991325 |
| Device Name: | MODIFICATION OF ENCORE LINEAR POROUS COATED HIP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Debbie De Los Santos |
| Correspondent | Debbie De Los Santos ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-19 |
| Decision Date | 1999-06-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912078221 | K991325 | 000 |
| 00888912077934 | K991325 | 000 |
| 00888912077927 | K991325 | 000 |
| 00888912077910 | K991325 | 000 |
| 00888912077897 | K991325 | 000 |
| 00888912077880 | K991325 | 000 |
| 00888912077873 | K991325 | 000 |
| 00888912077866 | K991325 | 000 |
| 00888912077859 | K991325 | 000 |
| 00888912077842 | K991325 | 000 |
| 00888912077835 | K991325 | 000 |
| 00888912077828 | K991325 | 000 |
| 00888912077941 | K991325 | 000 |
| 00888912078085 | K991325 | 000 |
| 00888912078092 | K991325 | 000 |
| 00888912078214 | K991325 | 000 |
| 00888912078207 | K991325 | 000 |
| 00888912078191 | K991325 | 000 |
| 00888912078184 | K991325 | 000 |
| 00888912078160 | K991325 | 000 |
| 00888912078153 | K991325 | 000 |
| 00888912078146 | K991325 | 000 |
| 00888912078139 | K991325 | 000 |
| 00888912078122 | K991325 | 000 |
| 00888912078115 | K991325 | 000 |
| 00888912078108 | K991325 | 000 |
| 00888912077811 | K991325 | 000 |