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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 4 of 102| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Stratum Ankle | SALS3566NS | FDA UDI | Class II | Active |
| Aptus | A-5880.20/1 | FDA UDI | Class II | Active |
| Aptus | A-5785.23/1 | FDA UDI | Class II | Active |
| Aptus | A-4851.26TP | EUDAMEDFDA UDI | Class II | Active |
| Aptus | A-5800.16/1 | FDA UDI | Class II | Active |
| Stratum Ankle | SALS5042NS | FDA UDI | Class II | Active |
| InCore TMT | IC-TMT-0109 | FDA UDI | Class I | Active |
| Aptus | A-5450.06/1 | FDA UDI | Class II | Active |
| Stratum | STRM-2LF-LGR | FDA UDI | Class II | Active |
| Stratum | STRM-NL-3534ST | FDA UDI | Class II | Active |
| Aptus | A-5282.06/1 | FDA UDI | Class II | Active |
| Aptus | A-5850.14 | FDA UDI | Class II | Active |
| Aptus | A-5250.18/1 | FDA UDI | Class II | Active |
| Stratum Ankle | SANLS3566S | FDA UDI | Class II | Active |
| Aptus | A-5830.75/1 | FDA UDI | Class II | Active |
| Aptus | A-4655.62 | FDA UDI | Class II | Active |
| Stratum Ankle | SALS3514NS | FDA UDI | Class II | Active |
| Nextra PEEK Hammertoe Correction System | PHANGD | FDA UDI | Class II | Active |
| Aptus | A-6710 | FDA UDI | Class II | Active |
| Aptus | A-6604.914 | EUDAMEDFDA UDI | Class II | Active |
| Axi+Line Bunion Correction System | SCR-3520NL | FDA UDI | Class II | Unknown |
| Stratum RS | STRM-MDS-2424RS-ST | FDA UDI | Class II | Active |
| InCore TMT | IC-TMT-0123 | FDA UDI | Class I | Active |
| Nextra CH | CH-MINI-KT | FDA UDI | Class II | Active |
| Aptus | A-4954.24S | FDA UDI | Class II | Active |
| Aptus | A-2913.1 | EUDAMEDFDA UDI | Class I | Active |
| Aptus | A-4950.72 | FDA UDI | Class II | Active |
| Aptus | A-3030.10 | EUDAMEDFDA UDI | Class I | Active |
| Aptus | A-6601.025 | FDA UDI | Class II | Active |
| Aptus | A-5500.30 | FDA UDI | Class II | Active |
| Aptus | A-4856.52 | FDA UDI | Class II | Active |
| Calcshift Instrument System | 1031-10009 | FDA UDI | Class I | Active |
| Aptus | A-5700.34C/1 | FDA UDI | Class II | Active |
| Aptus | A-5850.20 | FDA UDI | Class II | Active |
| Calcshift Instrument System | 1031-11013 | FDA UDI | Class I | Active |
| Aptus | A-5850.75/1S | FDA UDI | Class II | Active |
| Stealthfix Intraosseous Fixation System | SF4335 | FDA UDI | Class I | Active |
| Aptus | A-8410.35/1 | FDA UDI | Class II | Active |
| Calcshift Instrument System | 1031-10008-1 | FDA UDI | Class I | Active |
| Aptus | A-5250.09/1 | FDA UDI | Class II | Active |
| Aptus | A-5042.00/1 | FDA UDI | Class II | Active |
| Aptus | A-4951.22 | FDA UDI | Class II | Active |
| Aptus | A-4750.52 | FDA UDI | Class II | Active |
| Aptus | A-8212.26/1 | FDA UDI | Class II | Active |
| Aptus | A-5800.18 | FDA UDI | Class II | Active |
| MSP Metatarsal Shortening Plate Kit | MS-SSR | FDA UDI | Class II | Active |
| Stratum | STRM-NL-2734ST | FDA UDI | Class II | Active |
| Stratum Ankle | SALS3522NS | FDA UDI | Class II | Active |
| Aptus | A-4660.10 | FDA UDI | Class II | Active |
| Aptus | A-6603.033 | EUDAMEDFDA UDI | Class II | 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. |