Hedron
HEDRON IA Spacer, 29x39, 13mm, 20°, Convex
1manufacturer
156catalogue numbers in this listing
Who Else Makes It
Registered in Shandong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
Record
| Listed by | Globus Medical, Inc., United States |
|---|---|
| FDA product code | PHM |
| Device type | Intervertebral Fusion Device With Bone Graft, Thoracic |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K191391 |
| Record published | 2021-07-03 |
| Record revised | 2025-07-14 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Height 11 to 25 mm; depth 24 to 29 mm; width 30 to 39 mm; angle 8 to 30 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1209.2267S | In distribution | |
| 1225.0117S | In distribution | |
| 1209.0261S | In distribution | |
| 1209.2051S | In distribution | |
| 1209.0217S | In distribution | |
| 1209.2131S | In distribution | |
| 1209.0177S | In distribution | |
| 1225.1015S | In distribution | |
| 1210.0255S | In distribution | |
| 1209.0303S | In distribution | |
| 1210.2187S | In distribution | |
| 1210.2257S | In distribution | |
| 1212.0721S | Height 21 mm | In distribution |
| 1210.2251S | In distribution | |
| 1209.1005S | In distribution | |
| 1210.0148S | In distribution | |
| 1209.0179S | In distribution | |
| 1210.0257S | In distribution | |
| 1212.0711S | Depth 26 mm | In distribution |
| 1209.0363S | In distribution | |
| 1210.0250S | In distribution | |
| 1209.1015S | In distribution | |
| 1209.0885S | In distribution | |
| 1212.1121S | Height 21 mm | In distribution |
| 1225.1007S | In distribution | |
| 1210.0216S | In distribution | |
| 1212.1111S | Angle 8 ° | In distribution |
| 1210.1194S | In distribution | |
| 1212.1015S | Height 15 mm | In distribution |
| 1209.1029S | In distribution | |
| 1225.0111S | In distribution | |
| 1209.0305S | In distribution | |
| 1209.0963S | In distribution | |
| 1212.0215S | Width 30 mm | In distribution |
| 1209.0339S | In distribution | |
| 1209.0979S | In distribution | |
| 1210.2157S | In distribution | |
| 1210.1291S | In distribution | |
| 1210.0117S | In distribution | |
| 1212.0315S | Angle 20 ° | In distribution |
| 1209.0921S | In distribution | |
| 1209.2129S | In distribution | |
| 1210.1154S | In distribution | |
| 1225.1109S | In distribution | |
| 1225.0007S | In distribution | |
| 1209.0977S | In distribution | |
| 1225.1117S | In distribution | |
| 1212.1113S | Angle 8 ° | In distribution |
| 1209.2075S | In distribution | |
| 1210.1252S | In distribution | |
| 1209.0281S | In distribution | |
| 1209.2089S | In distribution | |
| 1210.2252S | In distribution | |
| 1210.2149S | In distribution | |
| 1210.1253S | In distribution | |
| 1210.1150S | In distribution | |
| 1209.2055S | In distribution | |
| 1212.1321S | Depth 29 mm | In distribution |
| 1209.0905S | In distribution | |
| 1209.0203S | In distribution | |
| 1212.3313S | In distribution | |
| 1210.0211S | In distribution | |
| 1225.0109S | In distribution | |
| 1209.0219S | In distribution | |
| 1225.0012S | In distribution | |
| 1209.1973S | In distribution | |
| 1210.1152S | In distribution | |
| 1209.0325S | In distribution | |
| 1209.0925S | In distribution | |
| 1212.0815S | Depth 26 mm | In distribution |
| 1210.0212S | In distribution | |
| 1209.1991S | In distribution | |
| 1210.2194S | In distribution | |
| 1212.1117S | Angle 8 ° | In distribution |
| 1210.0252S | In distribution | |
| 1225.1013S | In distribution | |
| 1210.1293S | In distribution | |
| 1210.1295S | In distribution | |
| 1225.1110S | In distribution | |
| 1209.1051S | In distribution | |
| 1209.0265S | In distribution | |
| 1209.2033S | In distribution | |
| 1210.1190S | In distribution | |
| 1210.2189S | In distribution | |
| 1209.0899S | In distribution | |
| 1210.1147S | In distribution | |
| 1210.0116S | In distribution | |
| 1209.2029S | In distribution | |
| 1212.0111S | Height 11 mm | In distribution |
| 1210.2155S | In distribution | |
| 1209.1031S | In distribution | |
| 1210.2292S | In distribution | |
| 1209.0337S | In distribution | |
| 1210.0108S | In distribution | |
| 1209.1011S | In distribution | |
| 1212.1021S | Angle 30 ° | In distribution |
| 1209.1989S | In distribution | |
| 7212.0030 | In distribution | |
| 1210.0154S | In distribution | |
| 1210.1192S | In distribution | |
| 1210.2147S | In distribution | |
| 1212.0417S | Depth 24 mm | In distribution |
| 1209.0201S | In distribution | |
| 1210.1250S | In distribution | |
| 1210.0251S | In distribution | |
| 1225.1115S | In distribution | |
| 1212.0713S | Depth 26 mm | In distribution |
| 1212.0917S | Width 34 mm | In distribution |
| 1212.2313S | In distribution | |
| 1209.0359S | In distribution | |
| 1209.2151S | In distribution | |
| 1209.0239S | In distribution | |
| 1209.0221S | In distribution | |
| 1209.2031S | In distribution | |
| 1209.0883S | In distribution | |
| 6210.0101 | In distribution | |
| 1209.1035S | In distribution | |
| 1210.1156S | In distribution | |
| 1210.1257S | In distribution | |
| 1210.1148S | In distribution | |
| 1225.0015S | In distribution | |
| 1210.1193S | In distribution | |
| 1212.1525S | Height 25 mm | In distribution |
| 1209.0997S | In distribution | |
| 1212.0421S | Angle 25 ° | In distribution |
| 6210.0001 | In distribution | |
| 1210.0150S | In distribution | |
| 1212.0617S | Height 17 mm | In distribution |
| 1209.0879S | In distribution | |
| 1210.2197S | In distribution | |
| 1210.0213S | In distribution | |
| 1209.0945S | In distribution | |
| 1209.0365S | In distribution | |
| 1209.0877S | In distribution | |
| 1209.1993S | In distribution | |
| 1209.0917S | In distribution | |
| 1210.0111S | In distribution | |
| 1210.2250S | In distribution | |
| 1225.0010S | In distribution | |
| 1209.2011S | In distribution | |
| 1225.1112S | In distribution | |
| 1212.0621S | Width 34 mm | In distribution |
| 1209.2133S | In distribution | |
| 1209.2013S | In distribution | |
| 1210.1251S | In distribution | |
| 1210.1195S | In distribution | |
| 1210.2153S | In distribution | |
| 1209.2153S | In distribution | |
| 1209.0241S | In distribution | |
| 1225.1113S | In distribution | |
| 1209.0199S | In distribution | |
| 1210.2293S | In distribution | |
| 1212.0719S | Depth 26 mm | In distribution |
| 1209.0341S | In distribution | |
| 1209.0223S | In distribution | |
| 1210.2290S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CoRoent | Nuvasive, Inc. | 2,299 |
| IdentiTi | Alphatec Spine, Inc. | 940 |
| Solar™ Interbody Fusion System | Degen Medical | 805 |
| Transcend Nanotec | Alphatec Spine, Inc. | 466 |
| IDENTITi Nanotec | Alphatec Spine, Inc. | 459 |
| E3D-A Interbody System | Evolution Spine, LLC | 308 |
| Battalion | Alphatec Spine, Inc. | 241 |
| Reef L | Seaspine Orthopedics Corporation | 207 |
| IdentiTi II | Alphatec Spine, Inc. | 163 |
| Modulus | Nuvasive, Inc. | 158 |
| Roccia | Silony Medical Gmbh | 133 |
| TLX | Nuvasive, Inc. | 88 |
Showing 12 of 41. All products under Intervertebral Fusion Device With Bone Graft, Thoracic
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.