FlareHawk
Shim, 11 mm or 13 mm x 23 mm/ 25 mm, 6 degree, FH11 Sterile
14manufacturers in China registered for this device type
243catalogue numbers in this listing
5recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Shandong (2), Shanghai (2). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Showing 12 of 14. All 14 manufacturers in China registered for Intervertebral Fusion Device With Bone Graft, Lumbar
Record
| Listed by | Highridge Medical, LLC, United States |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K202198 |
| Record published | 2025-10-03 |
| Record revised | 2026-03-23 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FHTPS206267S | In distribution | |
| FHTAS206299S | In distribution | |
| FHTPGP1A | In distribution | |
| FHTACT0927H | In distribution | |
| FHTAS40627X | In distribution | |
| FHTAS10627O | In distribution | |
| FHTGS20625A | In distribution | |
| II-1-0188 | In distribution | |
| FHPAS30023S | In distribution | |
| 0 | In distribution | |
| ASY-01169 | In distribution | |
| FHTA-S2-06-27-B | In distribution | |
| FHTGS00025A | In distribution | |
| 0 | In distribution | |
| FHTPS306307S | In distribution | |
| FHPACS0025TT | In distribution | |
| FHPACS0025PTS | In distribution | |
| FHTAS106299S | In distribution | |
| FHPAS20623X | In distribution | |
| FHTACS0029TT | In distribution | |
| FHTAS10627X | In distribution | |
| FHTA-S2-00-27-B | In distribution | |
| FHTPS10630S | In distribution | |
| FHTGS10625A | In distribution | |
| FHTAS10627S | In distribution | |
| FHPAS000259S | In distribution | |
| FHPACT0925TT | In distribution | |
| CMP-00610 | In distribution | |
| 0 | In distribution | |
| FHPA-CS-00-23-B | In distribution | |
| FHTAS50627X | In distribution | |
| FHTA-S1-06-27-B | In distribution | |
| FHTA-CT-00-27-B2 | In distribution | |
| FHTGS20025A | In distribution | |
| FHTAS50627O | In distribution | |
| FHPA-S2-06-23-B | In distribution | |
| II-1-0037 | In distribution | |
| 0 | In distribution | |
| FHPACT0025TTS | In distribution | |
| FHTPS10626S | In distribution | |
| FHPACT0925TTS | In distribution | |
| FHTAS20627O | In distribution | |
| FHPAS10023X | In distribution | |
| FHTGS300291S | In distribution | |
| II-1-0189 | In distribution | |
| FHTAS20027S | In distribution | |
| FHTAS20627X | In distribution | |
| FHPAS200259S | In distribution | |
| FHTPS30626S | In distribution | |
| FHTAS40623O | In distribution | |
| FHTPCT0030PTS | In distribution | |
| FHTGS206251S | In distribution | |
| FHPA-CT-00-23-B2 | In distribution | |
| FHTAS30027X | In distribution | |
| ASY-00165 | In distribution | |
| FHPAS40023X | In distribution | |
| FHTA-S3-06-27-B | In distribution | |
| FHPACT0025PTS | In distribution | |
| FHTAS400299S | In distribution | |
| FHTGS10629A | In distribution | |
| FHPAS106259S | In distribution | |
| FHPAS40623X | In distribution | |
| FHTACS0027SB | In distribution | |
| 0 | In distribution | |
| FHTA-S4-00-27-B | In distribution | |
| FHPAS400259S | In distribution | |
| FHTPCS0026PTS | In distribution | |
| FHTA-GP-27-A | In distribution | |
| FHTPS300307S | In distribution | |
| FHTAS300299S | In distribution | |
| FHTGS200291S | In distribution | |
| II-1-0190 | In distribution | |
| FHPAS10623X | In distribution | |
| FHPAS20625OS | In distribution | |
| FHTPS40030S | In distribution | |
| FHTA-CS-00-27-B | In distribution | |
| FHTAS100299S | In distribution | |
| FHPA-CS-00-23-B2 | In distribution | |
| FHPAS206259S | In distribution | |
| FHTPS40026S | In distribution | |
| CMP-00916 | In distribution | |
| FHTAS30627X | In distribution | |
| FHPAS50023X | In distribution | |
| FHTA-CS-00-27-B2 | In distribution | |
| 0 | In distribution | |
| FHTPCT0026PTS | In distribution | |
| FHTAS40027X | In distribution | |
| FHTAS30627O | In distribution | |
| FHTAS10027X | In distribution | |
| FHTACT0929TT | In distribution | |
| FHTAS10629OS | In distribution | |
| FHTGS30025A | In distribution | |
| FHTPS206307S | In distribution | |
| 0 | In distribution | |
| 0 | In distribution | |
| FHTPS106267S | In distribution | |
| FHTACS0029PTS | In distribution | |
| FHTPS30630S | In distribution | |
| FHTAS30027S | In distribution | |
| FHPA-S1-00-23-B | In distribution | |
| FHPAS20023S | In distribution | |
| FHPAS40023S | In distribution | |
| FHTPS400307S | In distribution | |
| FHTPS30030S | In distribution | |
| II-1-0185 | In distribution | |
| FHTPS500267S | In distribution | |
| ASY-00120 | In distribution | |
| FHPA-S3-00-23-B | In distribution | |
| FHTAS50623O | In distribution | |
| FHTGS106251S | In distribution | |
| II-1-0093 | In distribution | |
| FHPA-S4-00-23-B | In distribution | |
| FHTGS106291S | In distribution | |
| FHTAS20629OS | In distribution | |
| FHTPS200307S | In distribution | |
| FHTACT0929TTS | In distribution | |
| FHTPS500307S | In distribution | |
| FHTPS20030S | In distribution | |
| FHTPS50030S | In distribution | |
| 0 | In distribution | |
| FHTGS206291S | In distribution | |
| FHTGS30629A | In distribution | |
| FHTPS100307S | In distribution | |
| FHTGS306291S | In distribution | |
| FHTGS300251S | In distribution | |
| FHTGS10025A | In distribution | |
| FHPAS60023X | In distribution | |
| FHTPCS0030PTS | In distribution | |
| FHTAS000299S | In distribution | |
| FHTPS50026S | In distribution | |
| 0 | In distribution | |
| FHTPCS0030C | In distribution | |
| 0 | In distribution | |
| FHTA-S1-00-27-B | In distribution | |
| II-1-0195 | In distribution | |
| FHTA-S3-00-27-B | In distribution | |
| FHTA-CT-00-27-B | In distribution | |
| ASY-00113 | In distribution | |
| 0 | In distribution | |
| ASY-00337 | In distribution | |
| FHTPCT0030C | In distribution | |
| FHTACT0029TTS | In distribution | |
| II-1-0186 | In distribution | |
| ASY-00424 | In distribution | |
| FHTACS0029TTS | In distribution | |
| II-1-0073 | In distribution | |
| FHPACT0023SB | In distribution | |
| FHPACT0925PTS | In distribution | |
| FHTGS400291S | In distribution | |
| FHPACT0025TT | In distribution | |
| FHPACT0923H | In distribution | |
| FHPAXT0023SB | In distribution | |
| 0 | In distribution | |
| 0 | In distribution | |
| FHPAXT0923H | In distribution | |
| 0 | In distribution | |
| FHTAXT0027SB | In distribution | |
| FHTGS306251S | In distribution | |
| FHPA-CT-00-23-B | In distribution | |
| FHTAS30623O | In distribution | |
| FHTACT0029TT | In distribution | |
| FHTAS50027X | In distribution | |
| FHTAS306299S | In distribution | |
| 0 | In distribution | |
| FHPAS10623S | In distribution | |
| FHPA-S1-06-23-B | In distribution | |
| FHTAS20627S | In distribution | |
| FHTGS20029A | In distribution | |
| FHTAS20623O | In distribution | |
| FHGP23 | In distribution | |
| FHPAS100259S | In distribution | |
| FHTPS20026S | In distribution | |
| FHPAS50623X | In distribution | |
| FHPA-S3-06-23-B | In distribution | |
| 0 | In distribution | |
| FHPAS30625OS | In distribution | |
| FHPACS0025TTS | In distribution | |
| 0 | In distribution | |
| FHPAS20023X | In distribution | |
| FHTAS10027S | In distribution | |
| II-1-0194 | In distribution | |
| FHTPCS0026C | In distribution | |
| FHTGS200251S | In distribution | |
| II-1-0191 | In distribution | |
| FHTPS30026S | In distribution | |
| FHPAS30023X | In distribution | |
| 0 | In distribution | |
| FHPAS20623S | In distribution | |
| ASY-00004 | In distribution | |
| FHPACS0023SB | In distribution | |
| FHTACT0027SB | In distribution | |
| II-1-0128 | In distribution | |
| FHTGS40029A | In distribution | |
| 0 | In distribution | |
| FHTAS40027S | In distribution | |
| FHTAS10623O | In distribution | |
| FHPAS300259S | In distribution | |
| FHTAXT0927H | In distribution | |
| FHTAS30629OS | In distribution | |
| FHPAS306259S | In distribution | |
| 0 | In distribution | |
| II-1-0187 | In distribution | |
| 0 | In distribution | |
| FHTGS00029A | In distribution | |
| FHTAS30627S | In distribution | |
| FHGPGUN | In distribution | |
| FHTPS200267S | In distribution | |
| FHTGS100251S | In distribution | |
| FHTPS306267S | In distribution | |
| FHTGS30625A | In distribution | |
| FHTPS400267S | In distribution | |
| FHPAS10023S | In distribution | |
| ASY-00317 | In distribution | |
| 0 | In distribution | |
| ASY-00316 | In distribution | |
| FHTPCT0026C | In distribution | |
| FHPAS10625OS | In distribution | |
| FHPAS30623X | In distribution | |
| 0 | In distribution | |
| FHTPS20630S | In distribution | |
| ASY-00143 | In distribution | |
| FHTACT0929PTS | In distribution | |
| FHTAS40627O | In distribution | |
| FHTPS20626S | In distribution | |
| FHTGS100291S | In distribution | |
| FHTACT0029PTS | In distribution | |
| FHTGS40025A | In distribution | |
| FHPAS30623S | In distribution | |
| FHTPS300267S | In distribution | |
| FHTPS100267S | In distribution | |
| FHTGS000291S | In distribution | |
| FHTGS30029A | In distribution | |
| FHPA-S2-00-23-B | In distribution | |
| FHTAS60027X | In distribution | |
| FHTGS000251S | In distribution | |
| FHTAS200299S | In distribution | |
| FHTAS20027X | In distribution | |
| FHTGS20629A | In distribution | |
| 0 | In distribution | |
| FHTGS400251S | In distribution | |
| FHTGS10029A | In distribution | |
| 0 | In distribution | |
| FHTPS106307S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Peridot Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 10,850 |
| Yellowstone | Summit Spine | 6,654 |
| CoRoent | Nuvasive, Inc. | 5,690 |
| Zavation | Zavation | 2,554 |
| Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2,533 |
| Talos® IBF | Meditech Spine, LLC | 2,163 |
| Peridot-PT Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 1,956 |
| TirboLOX-L Lumbar Ibfd | Captiva Spine, Inc. | 1,926 |
| Endoskeleton® TL | Titan Spine, LLC | 1,896 |
| Evos Lumbar Interbody System | Cutting Edge Spine | 1,871 |
| Epiphany | Pantheon Spinal LLC | 1,507 |
| LnK Lumbar Interbody Fusion Cage System | L&K Biomed Co., Ltd. | 1,506 |
Showing 12 of 1,958. All products under Intervertebral Fusion Device With Bone Graft, Lumbar
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Integrity Implants, Inc. | 510(k) number | 2018-02-27 | Class II | Under Investigation by firm | Recently Integrity Implants uncovered a discrepancy in the cleaning parameters in several of their labeling material. The firm is initiating the field correction to ensure that updated information is provided to all accounts. | 75 sets | 2019-05-06 |
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-03-16 | Class II | Device Design | Zimmer Biomet is recalling the Altius M-INI OCT Posterior Spinal Fixation System because the driver is unable to mate with the screw head tulip. | 141 | 2018-07-30 |
| 2016-06-30 | Class II | Under Investigation by firm | Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston Transform Instrument Case and Zyston Transform Implant Kit because the locking mechanism on the implant is not functioning as intended. | 5 | 2017-03-15 |
| 2016-06-30 | Class II | Under Investigation by firm | Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston Transform Instrument Case and Zyston Transform Implant Kit because the locking mechanism on the implant is not functioning as intended. | 5 | 2017-03-15 |
| 2012-02-22 | Class II | Nonconforming Material/Component | Biomet Spine, LLC is recalling the Timberline Cranial Caudal and Posterior Blades, 40-180mm due to oversize of the set screw hex feature. | 213 | 2015-03-23 |
| 2011-03-09 | Class II | Device Design | Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly. | 120 | 2015-01-07 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P000028 | 2004-06-18 | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM | Medtronic Sofamor Danek USA, Inc. |
| P970015 | 2003-09-10 | LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE | Sofamor Danek |
| P980048 | 2001-04-20 | BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM | Sulzer Spine-Tech |
| P950019 | 1999-03-19 | RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION | Stryker Spine |
| P950002 | 1997-06-30 | BAK INTERBODY FUSION SYSTEM | Zimmer Spine, Inc. |
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.