The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve.
| Device ID | K082844 |
| 510k Number | K082844 |
| Device Name: | BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Teffany Hutto |
| Correspondent | Teffany Hutto ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-26 |
| Decision Date | 2008-11-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912076111 | K082844 | 000 |
| 00888912076166 | K082844 | 000 |
| 00888912076159 | K082844 | 000 |
| 00888912076142 | K082844 | 000 |
| 00888912076135 | K082844 | 000 |
| 00888912076128 | K082844 | 000 |
| 00888912076104 | K082844 | 000 |
| 00888912076098 | K082844 | 000 |
| 00888912076081 | K082844 | 000 |
| 00888912076074 | K082844 | 000 |
| 00888912076067 | K082844 | 000 |
| 00888912076050 | K082844 | 000 |
| 00888912023313 | K082844 | 000 |
| 00888912076180 | K082844 | 000 |
| 00888912076197 | K082844 | 000 |
| 00888912076340 | K082844 | 000 |
| 00888912076333 | K082844 | 000 |
| 00888912076326 | K082844 | 000 |
| 00888912076302 | K082844 | 000 |
| 00888912076289 | K082844 | 000 |
| 00888912076265 | K082844 | 000 |
| 00888912076258 | K082844 | 000 |
| 00888912076241 | K082844 | 000 |
| 00888912076234 | K082844 | 000 |
| 00888912076227 | K082844 | 000 |
| 00888912076210 | K082844 | 000 |
| 00888912076203 | K082844 | 000 |
| 00888912023306 | K082844 | 000 |