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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 3 of 102| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Aptus | A-5886.25/1 | FDA UDI | Class II | Active |
| Axi+Line Bunion Correction System | SCR-3516L | FDA UDI | Class II | Unknown |
| InCore Subtalar | ICSUB55086 | FDA UDI | Class II | Active |
| Aptus | A-8117.50/1 | FDA UDI | Class II | Active |
| Aptus | A-6604.226 | EUDAMEDFDA UDI | Class I | Active |
| Aptus | A-6604.111 | EUDAMEDFDA UDI | Class I | Active |
| Stratum RS | STRM-L5-LT-RS | FDA UDI | Class II | Active |
| Stratum Ankle | SANLS3524NS | FDA UDI | Class II | Active |
| Aptus | A-5850.20/1S | FDA UDI | Class II | Active |
| Aptus | A-4851.23TP | EUDAMEDFDA UDI | Class II | Active |
| Aptus | A-5750.08/1 | FDA UDI | Class II | Active |
| Aptus | A-6602.018 | EUDAMEDFDA UDI | Class I | Active |
| Aptus | A-2311 | EUDAMEDFDA UDI | Class I | Active |
| Aptus | A-5250.16/1S | FDA UDI | Class II | Active |
| Aptus | A-6603.071 | FDA UDI | Class II | Active |
| Aptus | A-4856.69S | EUDAMEDFDA UDI | Class II | Active |
| Stratum | STRM-NL-3528ST | FDA UDI | Class II | Active |
| Aptus | A-5781.26/1 | FDA UDI | Class II | Active |
| Stratum Ankle | SACAN6028 | FDA UDI | Class II | Active |
| Aptus | A-8411.140/1 | FDA UDI | Class II | Active |
| Aptus | A-5800.28/1 | FDA UDI | Class II | Active |
| Aptus | A-5043.00 | FDA UDI | Class II | Active |
| Aptus | A-5880.36/1 | FDA UDI | Class II | Active |
| Aptus | A-5900.60/1 | FDA UDI | Class II | Active |
| Aptus | A-5850.30/1 | FDA UDI | Class II | Active |
| Aptus | A-5200.08/1S | EUDAMEDFDA UDI | Class II | Active |
| Stratum Ankle | SANLS5022NS | FDA UDI | Class II | Active |
| Aptus | A-4600.20 | FDA UDI | Class II | Active |
| Aptus | A-5200.21/1 | FDA UDI | Class II | Active |
| InCore TMT | IC-TMT-4918RP | FDA UDI | Class II | Active |
| Aptus | A-5901.10/1 | FDA UDI | Class II | Active |
| Aptus | A-5785.28/1 | EUDAMEDFDA UDI | Class II | Active |
| Aptus | A-5040.51/4S | FDA UDI | Class II | Active |
| Aptus | A-5200.23/1 | FDA UDI | Class II | Active |
| Aptus | A-5200.16/1 | FDA UDI | Class II | Active |
| Aptus | A-4854.05 | FDA UDI | Class II | Active |
| Stealthfix Intraosseous Fixation System | SF3522 | FDA UDI | Class II | Active |
| Aptus | A-6606.052 | EUDAMEDFDA UDI | Class II | Active |
| Stratum RS | STRM-NL-2424RS-ST | FDA UDI | Class II | Active |
| Aptus | A-5755.20 | FDA UDI | Class II | Active |
| Aptus | A-5150.09 | FDA UDI | Class II | Active |
| Aptus | A-6604.155 | EUDAMEDFDA UDI | Class I | Active |
| Stratum Ankle | TRLTTSTLT | FDA UDI | Class I | Active |
| Aptus | A-5281.18/1 | FDA UDI | Class II | Active |
| Aptus | A-6601.037 | FDA UDI | Class II | Active |
| Aptus | A-4350.17 | FDA UDI | Class II | Active |
| Aptus | A-5400.15/1 | FDA UDI | Class II | Active |
| Axi+Line Bunion Correction System | AXL-075R | FDA UDI | Class II | Active |
| Aptus | A-5200.24/1S | FDA UDI | Class II | Active |
| Aptus | A-5786.29/1 | 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. |