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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 2 of 102| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Stratum Ankle | TRLTTSTRT | FDA UDI | Class I | Active |
| Stratum Ankle | SANLS5068NS | FDA UDI | Class II | Active |
| Stratum Ankle | SANLS3514NS | FDA UDI | Class II | Active |
| Nextra PEEK Hammertoe Correction System | PH32PKT | FDA UDI | Class II | Active |
| InCore TMT | IC-TMT-0117 | FDA UDI | Class I | Active |
| Stratum Ankle | SALS5078NS | FDA UDI | Class II | Active |
| Aptus | A-5830.50/1 | FDA UDI | Class II | Active |
| Aptus | A-4645.02 | FDA UDI | Class II | Active |
| Aptus | A-5950.30 | FDA UDI | Class II | Active |
| Aptus | A-8412.40/1 | FDA UDI | Class II | Active |
| Aptus | A-4851.24 | FDA UDI | Class II | Active |
| Aptus | A-5210.08 | FDA UDI | Class II | Active |
| Aptus | A-5885.17/1 | FDA UDI | Class II | Active |
| Stratum | STRM-NL-3520ST | FDA UDI | Class II | Active |
| Axi+Line Bunion Correction System | SCR-3516NL | FDA UDI | Class II | Active |
| Aptus | A-2791.06 | EUDAMEDFDA UDI | Class I | Active |
| Stratum Ankle | SAOUTCANS | FDA UDI | Class I | Active |
| General Instrument | LAP-CUT-GUIDE | FDA UDI | Class I | Active |
| Aptus | A-5800.12 | FDA UDI | Class II | Active |
| Aptus | A-6603.095 | EUDAMEDFDA UDI | Class II | Active |
| Aptus | A-4860.18 | FDA UDI | Class II | Active |
| Stealthfix Intraosseous Fixation System | SF2425 | FDA UDI | Class I | Active |
| Aptus | A-5250.07/1S | FDA UDI | Class II | Active |
| Nextra Hammertoe Correction System | NX-32K-SC | FDA UDI | Class II | Active |
| Aptus | A-5901.45/1 | FDA UDI | Class II | Active |
| Stratum Ankle | SAOT35DRVNS | FDA UDI | Class I | Active |
| Stratum RS | STRM-NL-2428RS-ST | FDA UDI | Class II | Active |
| Stratum Ankle | SANLS5062NS | FDA UDI | Class II | Active |
| Aptus | A-5850.12 | FDA UDI | Class II | Active |
| Aptus | A-5281.10/1 | FDA UDI | Class II | Active |
| Stratum | STRM-NL-2752ST | FDA UDI | Class II | Active |
| Aptus | A-2050 | EUDAMEDFDA UDI | Class I | Active |
| Aptus | A-5755.24C/1 | FDA UDI | Class II | Active |
| Aptus | A-5700.11/1 | FDA UDI | Class II | Active |
| Aptus | A-4954.102 | FDA UDI | Class II | Active |
| Aptus | A-5040.41/1 | FDA UDI | Class II | Active |
| Aptus | A-5800.28 | FDA UDI | Class II | Active |
| Aptus | A-4860.15 | FDA UDI | Class II | Active |
| Aptus | A-4950.14 | FDA UDI | Class II | Active |
| Stratum RS | STRM-MDS-2432RS-ST | FDA UDI | Class II | Active |
| Aptus | A-8416.45/1 | FDA UDI | Class II | Active |
| Aptus | A-5200.22 | FDA UDI | Class II | Active |
| Aptus | A-5880.18/1 | FDA UDI | Class II | Active |
| Aptus | A-5400.15 | FDA UDI | Class II | Active |
| InCore Subtalar | ICSUBCFL | FDA UDI | Class I | Active |
| Aptus | A-5800.50 | FDA UDI | Class II | Active |
| Aptus | A-2235 | EUDAMEDFDA UDI | Class I | Active |
| Aptus | A-6602.016 | EUDAMEDFDA UDI | Class I | Active |
| Aptus | A-5040.90/1S | FDA UDI | Class II | Active |
| Aptus | A-8417.95/1 | FDA 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. |