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US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 1195 Polk Drive, Warsaw, IN, 46582
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3009540749
- DUNS Number
- 192756786
Catalogue (5070)
Page 1 of 102| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Aptus | A-6604.121 | EUDAMEDFDA UDI | Class I | Active |
| Aptus | A-5800.32/1 | FDA UDI | Class II | Active |
| Stratum Ankle | SACAN6085 | FDA UDI | Class II | Active |
| Aptus | A-2716 | EUDAMEDFDA UDI | Class I | Active |
| Aptus | A-6602.029 | EUDAMEDFDA UDI | Class I | Active |
| Aptus | A-5250.20/1 | FDA UDI | Class II | Active |
| Stratum Ankle | SA27DRLS | FDA UDI | Class I | Active |
| Aptus | A-4750.20 | FDA UDI | Class II | Active |
| Aptus | A-4760.13S | EUDAMEDFDA UDI | Class II | Active |
| Aptus | A-5411.12/1 | FDA UDI | Class II | Active |
| Aptus | A-5830.65/1 | FDA UDI | Class II | Active |
| Aptus | A-5040.21 | FDA UDI | Class II | Active |
| Aptus | A-6070.48 | FDA UDI | Class I | Active |
| Aptus | A-5750.10/1 | FDA UDI | Class II | Active |
| Aptus | A-6604.117 | EUDAMEDFDA UDI | Class I | Active |
| Aptus | A-8415.100/1 | FDA UDI | Class II | Active |
| Aptus | A-5901.10/1 | FDA UDI | Class II | Active |
| Aptus | A-6603.421 | EUDAMEDFDA UDI | Class II | Active |
| Aptus | A-6610.91 | FDA UDI | Class II | Active |
| Aptus | A-5100.09 | FDA UDI | Class II | Active |
| Aptus | A-4650.20 | FDA UDI | Class II | Active |
| InCore Subtalar | ICSUB55084 | FDA UDI | Class II | Active |
| Stratum RS | STRM-HS8-LT-RS | FDA UDI | Class II | Active |
| Aptus | A-5600.06 | FDA UDI | Class II | Active |
| Aptus | A-4700.70 | EUDAMEDFDA UDI | Class II | Active |
| Aptus | A-4856.93TP | EUDAMEDFDA UDI | Class I | Active |
| Aptus | A-6603.014 | EUDAMEDFDA UDI | Class I | Active |
| Aptus | A-7010 | EUDAMEDFDA UDI | Class I | Active |
| Aptus | A-8116.32/1 | FDA UDI | Class II | Active |
| Aptus | A-5850.55/1 | FDA UDI | Class II | Active |
| Aptus | A-5800.08/1S | FDA UDI | Class II | Active |
| Aptus | A-2722 | FDA UDI | Class I | Active |
| Aptus | A-5901.45/1S | FDA UDI | Class II | Active |
| Aptus | A-5886.22/1 | FDA UDI | Class II | Active |
| InCore Subtalar | ICSUB55092 | FDA UDI | Class II | Active |
| Axi+Line Bunion Correction System | AXJ-125L | FDA UDI | Class II | Active |
| Aptus | A-5500.24/1 | FDA UDI | Class II | Active |
| Aptus | A-5450.06/1S | FDA UDI | Class II | Active |
| Aptus | A-5046.21/2S | EUDAMEDFDA UDI | Class I | Active |
| Re+Line Bunion Correction System | RS-DR | FDA UDI | Class I | Active |
| Stratum | STRM-MDS-3530ST | FDA UDI | Class II | Active |
| Lapiprep Lapidus Preparation System | LPTISRET | FDA UDI | Class I | Active |
| Aptus | A-8416.100/1 | FDA UDI | Class II | Active |
| Aptus | A-6603.034 | EUDAMEDFDA UDI | Class II | Active |
| Calcshift Instrument System | 1031-10018 | FDA UDI | Class II | Active |
| Stratum Ankle | SALS5036NS | FDA UDI | Class II | Active |
| Aptus | A-6603.111 | EUDAMEDFDA UDI | Class II | Active |
| Aptus | A-4954.39S | FDA UDI | Class II | Active |
| Aptus | A-5800.36/1S | FDA UDI | Class II | Active |
| Aptus | A-6603.025 | EUDAMEDFDA UDI | Class I | Active |
Related Companies
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 12, 2024 | Z-1821-2024 | — | open, classified | Screw is 16mm long instead of 22mm long. |
| Oct 1, 2014 | Z-0150-2015 | — | terminated | A recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of breakage of the temporary tension bolt. |