Transcend Nanotec
TRANSCEND NANOTEC LIF-HL PEEK SPACER, 10 x 18 x 40 mm, 30°
1manufacturer
466catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Alphatec Spine, 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 | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K211805 |
| Record published | 2021-12-29 |
| Record revised | 2022-11-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Width 9 to 26 mm; height 4 to 16 mm; length 22 to 65 mm; angle 5 to 30 °; depth 22 to 35 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 101-PRO-04225030-S | Width 22 mm | In distribution |
| 101-PRO-07185005-S | Angle 5 ° | In distribution |
| 101-PRO-13163510-S | Width 16 mm | In distribution |
| 101-PRO-05264030-S | Length 40 mm | In distribution |
| 101-PRO-07226520-S | Height 7 mm | In distribution |
| 101-PRO-07185525-S | Length 55 mm | In distribution |
| 140-PRO-10092220-S | Length 22 mm | In distribution |
| 101-PRO-04264510-S | Width 26 mm | In distribution |
| 101-PRO-07164500-S | Width 16 mm | In distribution |
| 101-PRO-10184030-S | Width 18 mm | In distribution |
| 101-PRO-13164000-S | Width 16 mm | In distribution |
| 101-PRO-04265015-S | Height 4 mm | In distribution |
| 101-PRO-12224010-S | Length 40 mm | In distribution |
| 101-PRO-08226505-S | Length 65 mm | In distribution |
| 101-PRO-06184520-S | Angle 20 ° | In distribution |
| 101-PRO-11264000-S | Length 40 mm | In distribution |
| 101-PRO-05184520-S | Angle 20 ° | In distribution |
| 101-PRO-10224030-S | Angle 30 ° | In distribution |
| 101-PRO-06265000-S | Length 50 mm | In distribution |
| 140-PRO-07092505-S | Width 9 mm | In distribution |
| 101-PRO-04264005-S | Angle 5 ° | In distribution |
| 101-PRO-15163510-S | Length 35 mm | In distribution |
| 101-PRO-11225525-S | Angle 25 ° | In distribution |
| 144-PRO-15102515-S | Angle 15 ° | In distribution |
| 101-PRO-12265015-S | Length 50 mm | In distribution |
| 101-PRO-05186515-S | Angle 15 ° | In distribution |
| 101-PRO-05186510-S | Angle 10 ° | In distribution |
| 101-PRO-09264515-S | Angle 15 ° | In distribution |
| 101-PRO-11225015-S | Length 50 mm | In distribution |
| 101-PRO-10266515-S | Length 65 mm | In distribution |
| 101-PRO-09184005-S | Length 40 mm | In distribution |
| 101-PRO-14225015-S | Height 14 mm | In distribution |
| 140-PRO-09092515-S | Angle 15 ° | In distribution |
| 101-PRO-06265005-S | Height 6 mm | In distribution |
| 101-PRO-13266500-S | Width 26 mm | In distribution |
| 101-PRO-06226015-S | Angle 15 ° | In distribution |
| 101-PRO-15225000-S | Height 15 mm | In distribution |
| 101-PRO-08265515-S | Length 55 mm | In distribution |
| 101-PRO-10226015-S | Length 60 mm | In distribution |
| 101-PRO-12264005-S | Height 12 mm | In distribution |
| 101-PRO-05264005-S | Width 26 mm | In distribution |
| 101-PRO-08266030-S | Length 60 mm | In distribution |
| 101-PRO-05226030-S | Angle 30 ° | In distribution |
| 101-PRO-05266510-S | Length 65 mm | In distribution |
| 101-PRO-14185025-S | Height 14 mm | In distribution |
| 101-PRO-07186030-S | Length 60 mm | In distribution |
| 101-PRO-05224010-S | Length 40 mm | In distribution |
| 140-PRO-15093010-S | Angle 10 ° | In distribution |
| 101-PRO-10225000-S | Length 50 mm | In distribution |
| 101-PRO-04226510-S | Height 4 mm | In distribution |
| 101-PRO-09186530-S | Height 9 mm | In distribution |
| 101-PRO-07185500-S | Height 7 mm | In distribution |
| 101-PRO-11186500-S | Height 11 mm | In distribution |
| 101-PRO-11264525-S | Length 45 mm | In distribution |
| 101-PRO-09164500-S | Width 16 mm | In distribution |
| 101-PRO-10185020-S | Width 18 mm | In distribution |
| 101-PRO-09162510-S | Angle 10 ° | In distribution |
| 144-PRO-09103505-S | Depth 35 mm | In distribution |
| 101-PRO-07266530-S | Length 65 mm | In distribution |
| 101-PRO-12226505-S | Width 22 mm | In distribution |
| 101-PRO-09224030-S | Angle 30 ° | In distribution |
| 101-PRO-12186020-S | Width 18 mm | In distribution |
| 101-PRO-08264500-S | Height 8 mm | In distribution |
| 144-PRO-13103010-S | Width 10 mm | In distribution |
| 101-PRO-12224005-S | Height 12 mm | In distribution |
| 101-PRO-04226025-S | Height 4 mm | In distribution |
| 101-PRO-05186030-S | Angle 30 ° | In distribution |
| 101-PRO-04264515-S | Length 45 mm | In distribution |
| 101-PRO-07226525-S | Height 7 mm | In distribution |
| 101-PRO-11264505-S | Height 11 mm | In distribution |
| 140-PRO-08092215-S | Height 8 mm | In distribution |
| 101-PRO-08224520-S | Angle 20 ° | In distribution |
| 101-PRO-08185015-S | Length 50 mm | In distribution |
| 101-PRO-09266510-S | Width 26 mm | In distribution |
| 101-PRO-10225530-S | Angle 30 ° | In distribution |
| 101-PRO-10162510-S | Height 10 mm | In distribution |
| 101-PRO-05266025-S | Angle 25 ° | In distribution |
| 140-PRO-09092505-S | Width 9 mm | In distribution |
| 101-PRO-04225520-S | Length 55 mm | In distribution |
| 101-PRO-08164500-S | Height 8 mm | In distribution |
| 101-PRO-05265030-S | Width 26 mm | In distribution |
| 101-PRO-12266505-S | Height 12 mm | In distribution |
| 144-PRO-14102505-S | Angle 5 ° | In distribution |
| 101-PRO-11225000-S | Width 22 mm | In distribution |
| 101-PRO-05186010-S | Height 5 mm | In distribution |
| 101-PRO-06184530-S | Length 45 mm | In distribution |
| 101-PRO-15225500-S | Height 15 mm | In distribution |
| 101-PRO-06266505-S | Width 26 mm | In distribution |
| 101-PRO-04225530-S | Angle 30 ° | In distribution |
| 144-PRO-10103015-S | Angle 15 ° | In distribution |
| 101-PRO-07226500-S | Width 22 mm | In distribution |
| 101-PRO-10225505-S | Length 55 mm | In distribution |
| 101-PRO-13264505-S | Length 45 mm | In distribution |
| 101-PRO-07164510-S | Angle 10 ° | In distribution |
| 101-PRO-07266520-S | Length 65 mm | In distribution |
| 101-PRO-12184520-S | Height 12 mm | In distribution |
| 101-PRO-08265010-S | Angle 10 ° | In distribution |
| 101-PRO-10265515-S | Length 55 mm | In distribution |
| 101-PRO-07184015-S | Angle 15 ° | In distribution |
| 101-PRO-04186020-S | Height 4 mm | In distribution |
| 101-PRO-11186515-S | Height 11 mm | In distribution |
| 101-PRO-04185510-S | Height 4 mm | In distribution |
| 140-PRO-11093015-S | Depth 30 mm | In distribution |
| 101-PRO-08265530-S | Length 55 mm | In distribution |
| 101-PRO-07266030-S | Width 26 mm | In distribution |
| 101-PRO-05185025-S | Angle 25 ° | In distribution |
| 101-PRO-12224015-S | Angle 15 ° | In distribution |
| 101-PRO-08184000-S | Length 40 mm | In distribution |
| 101-PRO-09265515-S | Length 55 mm | In distribution |
| 101-PRO-10265025-S | Width 26 mm | In distribution |
| 101-PRO-13186020-S | Width 18 mm | In distribution |
| 101-PRO-16186500-S | Width 18 mm | In distribution |
| 101-PRO-12266520-S | Length 65 mm | In distribution |
| 144-PRO-09102515-S | Depth 25 mm | In distribution |
| 101-PRO-09185505-S | Length 55 mm | In distribution |
| 101-PRO-08265030-S | Length 50 mm | In distribution |
| 101-PRO-15163010-S | Height 15 mm | In distribution |
| 101-PRO-07266025-S | Length 60 mm | In distribution |
| 101-PRO-06185505-S | Width 18 mm | In distribution |
| 101-PRO-04264020-S | Length 40 mm | In distribution |
| 144-PRO-12103015-S | Height 12 mm | In distribution |
| 101-PRO-12184025-S | Width 18 mm | In distribution |
| 101-PRO-11226005-S | Length 60 mm | In distribution |
| 101-PRO-14224020-S | Height 14 mm | In distribution |
| 101-PRO-07185510-S | Angle 10 ° | In distribution |
| 101-PRO-11224520-S | Angle 20 ° | In distribution |
| 101-PRO-06224030-S | Width 22 mm | In distribution |
| 101-PRO-08163000-S | Width 16 mm | In distribution |
| 101-PRO-08266020-S | Length 60 mm | In distribution |
| 101-PRO-07184500-S | Length 45 mm | In distribution |
| 101-PRO-09226030-S | Length 60 mm | In distribution |
| 101-PRO-06163510-S | Length 35 mm | In distribution |
| 101-PRO-11164500-S | Height 11 mm | In distribution |
| 101-PRO-14226020-S | Length 60 mm | In distribution |
| 101-PRO-14184510-S | Length 45 mm | In distribution |
| 101-PRO-13265505-S | Height 13 mm | In distribution |
| 101-PRO-07264030-S | Length 40 mm | In distribution |
| 101-PRO-12225015-S | Width 22 mm | In distribution |
| 101-PRO-08226530-S | Height 8 mm | In distribution |
| 101-PRO-13224520-S | Height 13 mm | In distribution |
| 140-PRO-08092220-S | Width 9 mm | In distribution |
| 140-PRO-14092220-S | Width 9 mm | In distribution |
| 140-PRO-14092510-S | Angle 10 ° | In distribution |
| 101-PRO-12264015-S | Width 26 mm | In distribution |
| 101-PRO-06226515-S | Angle 15 ° | In distribution |
| 101-PRO-05185505-S | Height 5 mm | In distribution |
| 101-PRO-09224025-S | Width 22 mm | In distribution |
| 140-PRO-11092510-S | Height 11 mm | In distribution |
| 101-PRO-11186030-S | Length 60 mm | In distribution |
| 101-PRO-14265010-S | Length 50 mm | In distribution |
| 101-PRO-05225025-S | Height 5 mm | In distribution |
| 101-PRO-05264515-S | Length 45 mm | In distribution |
| 101-PRO-05265515-S | Length 55 mm | In distribution |
| 101-PRO-06224005-S | Angle 5 ° | In distribution |
| 101-PRO-07264010-S | Height 7 mm | In distribution |
| 101-PRO-12184505-S | Width 18 mm | In distribution |
| 101-PRO-08225020-S | Width 22 mm | In distribution |
| 101-PRO-06225510-S | Angle 10 ° | In distribution |
| 101-PRO-10224010-S | Angle 10 ° | In distribution |
| 101-PRO-11266525-S | Angle 25 ° | In distribution |
| 101-PRO-12224520-S | Length 45 mm | In distribution |
| 101-PRO-12224515-S | Angle 15 ° | In distribution |
| 101-PRO-08184020-S | Angle 20 ° | In distribution |
| 101-PRO-04186525-S | Height 4 mm | In distribution |
| 101-PRO-11266005-S | Angle 5 ° | In distribution |
| 101-PRO-14185500-S | Length 55 mm | In distribution |
| 101-PRO-09264020-S | Height 9 mm | In distribution |
| 101-PRO-10266525-S | Width 26 mm | In distribution |
| 101-PRO-11226025-S | Length 60 mm | In distribution |
| 101-PRO-07225025-S | Width 22 mm | In distribution |
| 101-PRO-04224005-S | Angle 5 ° | In distribution |
| 101-PRO-05185520-S | Angle 20 ° | In distribution |
| 101-PRO-09163510-S | Angle 10 ° | In distribution |
| 101-PRO-10225520-S | Length 55 mm | In distribution |
| 101-PRO-05184525-S | Length 45 mm | In distribution |
| 101-PRO-08265020-S | Length 50 mm | In distribution |
| 101-PRO-14264510-S | Angle 10 ° | In distribution |
| 101-PRO-12226510-S | Height 12 mm | In distribution |
| 101-PRO-09226000-S | Length 60 mm | In distribution |
| 101-PRO-14164000-S | Width 16 mm | In distribution |
| 101-PRO-15163000-S | Height 15 mm | In distribution |
| 144-PRO-08103010-S | Height 8 mm | In distribution |
| 101-PRO-06225505-S | Length 55 mm | In distribution |
| 101-PRO-12266515-S | Angle 15 ° | In distribution |
| 101-PRO-09226525-S | Width 22 mm | In distribution |
| 140-PRO-08092205-S | Height 8 mm | In distribution |
| 140-PRO-08093015-S | Height 8 mm | In distribution |
| 101-PRO-13264015-S | Length 40 mm | In distribution |
| 101-PRO-09184525-S | Angle 25 ° | In distribution |
| 101-PRO-16163510-S | Angle 10 ° | In distribution |
| 101-PRO-12226005-S | Length 60 mm | In distribution |
| 101-PRO-11224530-S | Width 22 mm | In distribution |
| 101-PRO-15163500-S | Width 16 mm | In distribution |
| 101-PRO-14265505-S | Length 55 mm | In distribution |
| 101-PRO-11185525-S | Height 11 mm | In distribution |
| 101-PRO-10185515-S | Length 55 mm | In distribution |
| 144-PRO-12102510-S | Width 10 mm | In distribution |
| 101-PRO-09266505-S | Length 65 mm | In distribution |
| 101-PRO-14266515-S | Angle 15 ° | In distribution |
| 101-PRO-04185030-S | Angle 30 ° | In distribution |
| 101-PRO-11225500-S | Width 22 mm | In distribution |
| 101-PRO-10224515-S | Height 10 mm | In distribution |
| 101-PRO-14264010-S | Width 26 mm | In distribution |
| 101-PRO-14224500-S | Height 14 mm | In distribution |
| 101-PRO-13184525-S | Height 13 mm | In distribution |
| 101-PRO-14266505-S | Width 26 mm | In distribution |
| 101-PRO-04264520-S | Height 4 mm | In distribution |
| 101-PRO-09226025-S | Height 9 mm | In distribution |
| 101-PRO-09226515-S | Length 65 mm | In distribution |
| 101-PRO-04224015-S | Height 4 mm | In distribution |
| 144-PRO-13102510-S | Height 13 mm | In distribution |
| 101-PRO-08265005-S | Angle 5 ° | In distribution |
| 101-PRO-13226510-S | Length 65 mm | In distribution |
| 101-PRO-14225500-S | Width 22 mm | In distribution |
| 101-PRO-06186505-S | Length 65 mm | In distribution |
| 101-PRO-06264005-S | Angle 5 ° | In distribution |
| 140-PRO-14092215-S | Angle 15 ° | In distribution |
| 101-PRO-14225020-S | Height 14 mm | In distribution |
| 101-PRO-07264515-S | Length 45 mm | In distribution |
| 101-PRO-12164510-S | Height 12 mm | In distribution |
| 101-PRO-12185000-S | Height 12 mm | In distribution |
| 101-PRO-09265500-S | Height 9 mm | In distribution |
| 101-PRO-09226500-S | Length 65 mm | In distribution |
| 101-PRO-10224520-S | Width 22 mm | In distribution |
| 101-PRO-09265010-S | Angle 10 ° | In distribution |
| 144-PRO-15103010-S | Angle 10 ° | In distribution |
| 101-PRO-15185000-S | Width 18 mm | In distribution |
| 101-PRO-08264030-S | Length 40 mm | In distribution |
| 144-PRO-14103015-S | Angle 15 ° | In distribution |
| 101-PRO-13266000-S | Length 60 mm | In distribution |
| 140-PRO-10092205-S | Depth 22 mm | In distribution |
| 101-PRO-14225510-S | Height 14 mm | In distribution |
| 144-PRO-07102505-S | Height 7 mm | In distribution |
| 101-PRO-06185515-S | Length 55 mm | In distribution |
| 101-PRO-11164510-S | Length 45 mm | In distribution |
| 101-PRO-06186010-S | Height 6 mm | In distribution |
| 101-PRO-13226010-S | Height 13 mm | In distribution |
| 101-PRO-06225005-S | Length 50 mm | In distribution |
| 101-PRO-08186525-S | Length 65 mm | In distribution |
| 101-PRO-04264505-S | Height 4 mm | In distribution |
| 101-PRO-12264000-S | Height 12 mm | In distribution |
| 144-PRO-12103005-S | Depth 30 mm | In distribution |
| 101-PRO-08266510-S | Length 65 mm | In distribution |
| 101-PRO-07265520-S | Angle 20 ° | In distribution |
| 101-PRO-11225530-S | Height 11 mm | In distribution |
| 101-PRO-04266530-S | Width 26 mm | In distribution |
| 101-PRO-14163000-S | Width 16 mm | In distribution |
| 101-PRO-13185515-S | Width 18 mm | In distribution |
| 101-PRO-15185500-S | Width 18 mm | In distribution |
| 101-PRO-07226015-S | Length 60 mm | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| 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 |
| Hedron | Globus Medical, Inc. | 156 |
| Roccia | Silony Medical Gmbh | 133 |
| TLX | Nuvasive, Inc. | 88 |
Showing 12 of 41. All products under Intervertebral Fusion Device With Bone Graft, Thoracic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K180480 | 2018-05-31 |
| K160958 | 2016-09-08 |
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.