The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Natural-knee Ii Posterior Stabilized (p.s.) Condylar Knee Tibial Inserts.
| Device ID | K983153 |
| 510k Number | K983153 |
| Device Name: | NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Denise Cuchene |
| Correspondent | Denise Cuchene SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-09 |
| Decision Date | 1998-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024451834 | K983153 | 000 |
| 00889024261600 | K983153 | 000 |
| 00889024261594 | K983153 | 000 |
| 00889024261587 | K983153 | 000 |
| 00889024261570 | K983153 | 000 |
| 00889024261563 | K983153 | 000 |
| 00889024261556 | K983153 | 000 |
| 00889024261549 | K983153 | 000 |
| 00889024261532 | K983153 | 000 |
| 00889024261525 | K983153 | 000 |
| 00889024261518 | K983153 | 000 |
| 00889024261501 | K983153 | 000 |
| 00889024261495 | K983153 | 000 |
| 00889024261488 | K983153 | 000 |
| 00889024261471 | K983153 | 000 |
| 00889024261464 | K983153 | 000 |
| 00889024261457 | K983153 | 000 |
| 00889024261020 | K983153 | 000 |
| 00889024261617 | K983153 | 000 |
| 00889024261624 | K983153 | 000 |
| 00889024451827 | K983153 | 000 |
| 00889024451810 | K983153 | 000 |
| 00889024261778 | K983153 | 000 |
| 00889024261761 | K983153 | 000 |
| 00889024261754 | K983153 | 000 |
| 00889024261747 | K983153 | 000 |
| 00889024261730 | K983153 | 000 |
| 00889024261723 | K983153 | 000 |
| 00889024261716 | K983153 | 000 |
| 00889024261709 | K983153 | 000 |
| 00889024261693 | K983153 | 000 |
| 00889024261686 | K983153 | 000 |
| 00889024261679 | K983153 | 000 |
| 00889024261662 | K983153 | 000 |
| 00889024261655 | K983153 | 000 |
| 00889024261648 | K983153 | 000 |
| 00889024261631 | K983153 | 000 |
| 00889024260993 | K983153 | 000 |