The following data is part of a premarket notification filed by Whiteside Biomechanics, Inc. with the FDA for Micro-seal Acetabular System.
| Device ID | K971718 |
| 510k Number | K971718 |
| Device Name: | MICRO-SEAL ACETABULAR SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | WHITESIDE BIOMECHANICS, INC. 12634 OLIVE BLVD. St. Louis, MO 63141 |
| Contact | Michael C Wall |
| Correspondent | Michael C Wall WHITESIDE BIOMECHANICS, INC. 12634 OLIVE BLVD. St. Louis, MO 63141 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-09 |
| Decision Date | 1997-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B046WA110320 | K971718 | 000 |
| B046WA11021 | K971718 | 000 |
| B046WA110220 | K971718 | 000 |
| B046WA110230 | K971718 | 000 |
| B046WA110240 | K971718 | 000 |
| B046WA110250 | K971718 | 000 |
| B046WA110260 | K971718 | 000 |
| B046WA110270 | K971718 | 000 |
| B046WA110280 | K971718 | 000 |
| B046WA110290 | K971718 | 000 |
| B046WA110300 | K971718 | 000 |
| B046WA110310 | K971718 | 000 |
| B046WA11020 | K971718 | 000 |