The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Biolox Delta Ceramic Heads With 100kgy E-poly Acetabular Liners.
| Device ID | K073102 |
| 510k Number | K073102 |
| Device Name: | BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Becky Earl |
| Correspondent | Becky Earl BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | LZO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | MAY |
| Subsequent Product Code | OQG |
| Subsequent Product Code | OQH |
| Subsequent Product Code | OQI |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-02 |
| Decision Date | 2007-11-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05019279316182 | K073102 | 000 |
| 00887868248528 | K073102 | 000 |
| 00887868248535 | K073102 | 000 |
| 00887868248542 | K073102 | 000 |
| 00887868248559 | K073102 | 000 |
| 05019279316144 | K073102 | 000 |
| 05019279316151 | K073102 | 000 |
| 05019279316168 | K073102 | 000 |
| 05019279316175 | K073102 | 000 |
| 00887868248511 | K073102 | 000 |