Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K103404
ANA0TOMICAL SHOULDER TM COMBINED SYSTEM · Zimmer GmbH · decided 2011-03-15 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Anatomical Shoulder™ | 01.04237.145 | Zimmer GmbH | HSD KWS KWT PHX | 00889024287105 |
| Bigliani/Flatow® | 00-4302-056-18 | Zimmer, Inc. | HSD KWS KWT | 00889024265868 |
| Bigliani/Flatow® | 4301-52-56 | Zimmer, Inc. | HSD KWS KWT | 00889024265318 |
| Bigliani/Flatow® | 4301-40-15 | Zimmer, Inc. | HSD KWS KWT | 00889024264960 |
| Bigliani/Flatow® | 4300-46-15 | Zimmer, Inc. | HSD KWS KWT | 00889024264038 |
| Bigliani/Flatow® | 4301-36-40 | Zimmer, Inc. | HSD KWS KWT | 00889024264878 |
| Bigliani/Flatow® Trabecular Metal™ | 4307-32-40 | Zimmer, Inc. | HSD KWS KWT | 00889024266636 |
| Bigliani/Flatow® Trabecular Metal™ | 4307-33 | Zimmer, Inc. | HSD KWS KWT | 00889024266667 |
| Bigliani/Flatow® | 4302-52-33 | Zimmer, Inc. | HSD KWS KWT | 00889024265837 |
| Anatomical Shoulder™ Bigliani/Flatow® | 01.04255.045 | Zimmer GmbH | HSD KWS KWT | 00889024287952 |
| Bigliani/Flatow® | 4301-52-33 | Zimmer, Inc. | HSD KWS KWT | 00889024265288 |
| Bigliani/Flatow® | 4302-52-30 | Zimmer, Inc. | HSD KWS KWT | 00889024265820 |
| Bigliani/Flatow® | 4302-46-19 | Zimmer, Inc. | HSD KWS KWT | 00889024265684 |
| Bigliani/Flatow® | 4303-75 | Zimmer, Inc. | HSD KWS KWT | 00889024266353 |
| Bigliani/Flatow® | 4301-73-01 | Zimmer, Inc. | HSD KWS KWT | 00889024265448 |
| Bigliani/Flatow® | 4302-52-46 | Zimmer, Inc. | HSD KWS KWT | 00889024633032 |
| Bigliani/Flatow® | 4301-65 | Zimmer, Inc. | HSD KWS KWT | 00889024265394 |
| Bigliani/Flatow® | 4301-46-33 | Zimmer, Inc. | HSD KWS KWT | 00889024265141 |
| Anatomical Shoulder™ | 01.04237.095 | Zimmer GmbH | HSD KWS KWT PHX | 00889024286993 |
| Bigliani/Flatow® | 4300-52-56 | Zimmer, Inc. | HSD KWS KWT | 00889024264205 |
| Bigliani/Flatow® | 4300-52-33 | Zimmer, Inc. | HSD KWS KWT | 00889024264175 |
| Bigliani/Flatow® Trabecular Metal™ | 4307-62 | Zimmer, Inc. | HSD KWS KWT | 00889024266735 |
| Bigliani/Flatow® | 4301-30-46 | Zimmer, Inc. | HSD KWS KWT | 00889024264786 |
| Bigliani/Flatow® | 4300-86 | Zimmer, Inc. | HSD KWS KWT | 00889024632981 |
| Anatomical Shoulder™ | 01.04237.066 | Zimmer GmbH | HSD KWS KWT PHX | 00889024286955 |