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FlareHawk Interbody Fusion System

EUDAMEDFDA UDI

Class I (EU MDR)

Ref II-1-0316Ref FHTACT0027SBModel ASY-00045Ref FTHPKW2Model CMP-00483Ref CMP-00511Ref II-1-0320Ref ASY-00153Ref ASY-00764Ref ASY-00447Ref II-1-0073Ref II-1-0482Ref ASY-00503Ref CMP-00610Ref II-1-0323Ref ASY-00491Ref ASY-00424 Ref ASY-00257Ref CMP-01512

by Integrity Implants Inc.

Identity

Trade Name
FlareHawk Interbody Fusion System EUDAMED
NA FDA UDI
N/A FDA UDI
FlareHawk FDA UDI
Generic Name
Bone file/rasp, manual, reusable FDA UDI
Spinal rongeur FDA UDI
Fluted surgical drill bit, reusable FDA UDI
Arthroscopic access cannula, reusable FDA UDI
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Orthopaedic surgical distractor, internal FDA UDI
Spinal implant trial FDA UDI
Endoscopic-access dilator, reusable FDA UDI
Spinal guidewire FDA UDI
Surgical instrument handle, torque-limiting FDA UDI
Polymeric spinal interbody fusion cage FDA UDI
Device Name
14mm Paddle Distractor EUDAMEDFDA UDI
Expandable Shaver, Blade, FH7 EUDAMEDFDA UDI
Micro Pituitary EUDAMEDFDA UDI
Tubular Retractor #3 - Beveled, 170mm, FH7 ENDO EUDAMEDFDA UDI
Inserter Offset Barrel EUDAMEDFDA UDI
9mm Shaver EUDAMEDFDA UDI
Obturator Impactor, Short EUDAMEDFDA UDI
12mm Shaver EUDAMEDFDA UDI
Insertion Instrument EUDAMEDFDA UDI
6 degree Expandable Trial, FlareHawk 7 EUDAMEDFDA UDI
Cannula #3- Short, Flat, 140mm, FH7 MIS EUDAMEDFDA UDI
Removal Dilator 1, FH7 EUDAMEDFDA UDI
K-Wire, Trocar Tip, 508mmL, FlareHawk 7 EUDAMEDFDA UDI
9 mm x 29 mm, 9 degree Distractor EUDAMEDFDA UDI
Shell, Tall 29 mm, FlareHawk 9 EUDAMEDFDA UDI
Torque Limiting T-Handle, 35 in-lb EUDAMED
Disc Drill, 7.5mm, FH7 EUDAMED
7.5 mm Disc Drill, FH7 FDA UDI
Torque Limiting T-Handle 35in-lb FDA UDI
Model / Reference
II-1-0316 EUDAMEDFDA UDI
ASY-00257 EUDAMEDFDA UDI
ASY-00447 EUDAMEDFDA UDI
ASY-00491 EUDAMEDFDA UDI
ASY-00503 EUDAMEDFDA UDI
CMP-00610 EUDAMEDFDA UDI
II-1-0320 EUDAMEDFDA UDI
ASY-00153 EUDAMEDFDA UDI
II-1-0323 EUDAMEDFDA UDI
II-1-0073 EUDAMEDFDA UDI
ASY-00424 EUDAMEDFDA UDI
ASY-00764 EUDAMEDFDA UDI
CMP-01512 EUDAMEDFDA UDI
CMP-00483 EUDAMEDFDA UDI
CMP-00511 EUDAMEDFDA UDI
II-1-0482 EUDAMEDFDA UDI
ASY-00045 EUDAMEDFDA UDI
FHTACT0027SB EUDAMED
FTHPKW2 EUDAMED
Description
Expandable Shaver, Blade, FH7 FDA UDI
Micro Pituitary FDA UDI
7.5 mm Disc Drill, FH7 FDA UDI
Tubular Retractor #3 - Beveled, 170mm, FH7 ENDO FDA UDI
Inserter Offset Barrel FDA UDI
9mm Shaver FDA UDI
Obturator Impactor, Short FDA UDI
12mm Shaver FDA UDI
Insertion Instrument FDA UDI
6 degree Expandable Trial, FlareHawk 7 FDA UDI
14mm Paddle Distractor FDA UDI
Cannula #3- Short, Flat, 140mm, FH7 MIS FDA UDI
Removal Dilator 1, FH7 FDA UDI
K-Wire, Trocar Tip, 508mmL, FlareHawk 7 FDA UDI
9 mm x 29 mm, 9 degree Distractor FDA UDI
Torque Limiting T-Handle 35in-lb FDA UDI
Shell, Tall 29 mm, FlareHawk 9 FDA UDI

Identifiers

Catalog Number
ASY-00257 FDA UDI
ASY-00447 FDA UDI
ASY-00491 FDA UDI
ASY-00503 FDA UDI
CMP-00610 FDA UDI
II-1-0320 FDA UDI
ASY-00153 FDA UDI
II-1-0323 FDA UDI
II-1-0073 FDA UDI
ASY-00424 FDA UDI
II-1-0316 FDA UDI
ASY-00764 FDA UDI
CMP-01512 FDA UDI
FTHPKW2 FDA UDI
CMP-00511 FDA UDI
II-1-0482 FDA UDI
FHTACT0027SB FDA UDI
Primary DI / UDI-DI
00850231007961 EUDAMEDFDA UDI
00810004729025 EUDAMEDFDA UDI
00810004728622 EUDAMEDFDA UDI
00810004729001 EUDAMEDFDA UDI
00810004729063 EUDAMEDFDA UDI
00810004727649 EUDAMEDFDA UDI
00818613020007 EUDAMEDFDA UDI
00810004722071 EUDAMEDFDA UDI
00818613020038 EUDAMEDFDA UDI
00850231007220 EUDAMEDFDA UDI
00810004728431 EUDAMEDFDA UDI
00810004721265 EUDAMEDFDA UDI
00840200403108 EUDAMEDFDA UDI
00810004722064 EUDAMEDFDA UDI
00810004727038 EUDAMEDFDA UDI
00818613020304 EUDAMEDFDA UDI
00810004723580 EUDAMEDFDA UDI
Basic UDI-DI
B-00850231007961 EUDAMED
B-00810004723580 EUDAMED
B-00810004722064 EUDAMED
B-00810004727038 EUDAMED
B-00818613020007 EUDAMED
B-00810004722071 EUDAMED
B-00810004721265 EUDAMED
B-00810004728622 EUDAMED
B-00850231007220 EUDAMED
B-00818613020304 EUDAMED
B-00810004729063 EUDAMED
B-00810004727649 EUDAMED
B-00818613020038 EUDAMED
B-00810004729001 EUDAMED
B-00810004728431 EUDAMED
B-00810004729025 EUDAMED
B-00840200403108 EUDAMED
510(k) Number
K182114 FDA UDI
K160076 FDA UDI
K183184 FDA UDI
FDA Product Code
LXH FDA UDI
HTX FDA UDI
HTW FDA UDI
MAX FDA UDI
HXI FDA UDI
EMDN Code
L0920 ORTHOPAEDIC SURGERY DISTRACTORS, REUSABLE EUDAMED
P09070199 SPINAL FUSION SYSTEMS - OTHER EUDAMED
P0999 ORTHOPAEDIC PROSTHESES, OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - OTHER EUDAMED
L091202 ORTHOPAEDIC SURGERY FILES, REUSABLE EUDAMED
L1907 ARTHROSCOPIC SURGERY CANNULAS, REUSABLE EUDAMED
L091307 ORTHOPAEDIC SURGERY RONGEURS, REUSABLE EUDAMED
L091106 INSTRUMENTS FOR THE PREPARATION OF TISSUE IMPLANTS IN ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY, REUSABLE EUDAMED
L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
P090799 SPINAL PROSTHESES AND STABILISATION SYSTEMS - OTHER EUDAMED
L0707020101 VALVE DILATORS, REUSABLE EUDAMED
GMDN Term
Bone file/rasp, manual, reusable FDA UDI
Spinal rongeur FDA UDI
Fluted surgical drill bit, reusable FDA UDI
Arthroscopic access cannula, reusable FDA UDI
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Orthopaedic surgical distractor, internal FDA UDI
Spinal implant trial FDA UDI
Endoscopic-access dilator, reusable FDA UDI
Spinal guidewire FDA UDI
Surgical instrument handle, torque-limiting FDA UDI
Polymeric spinal interbody fusion cage FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
888.4540 FDA UDI
888.3080 FDA UDI
Market of Registration
Spain EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDIFDA UDI

Implantable

No

EUDAMEDFDA UDIEUDAMEDFDA UDI

Reusable

Yes

EUDAMEDEUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDIFDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

FlareHawk Interbody Fusion System by Integrity Implants Inc. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Integrity Implants Inc.
EUDAMED SRN
US-MF-000009805
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (34)

  • EUDAMED 3661bf3a-635b-4ed4-bf71-afa8ff0a38b1 61 fields · synced Sep 18, 2026
  • FDA UDI edd76969-ce73-44ca-b0a9-81cc1f700764 35 fields · synced May 24, 2026
  • FDA UDI 0b5ca612-bffa-46b0-b477-e9cb799db292 35 fields · synced May 29, 2026
  • FDA UDI 8b5927de-e6fb-4905-967d-187311f76608 35 fields · synced May 29, 2026
  • FDA UDI af970ce5-774f-4cb2-896c-99dc6c904001 35 fields · synced May 29, 2026
  • FDA UDI c6e9f1ce-b69e-4362-addd-b1de51340735 36 fields · synced May 30, 2026
  • FDA UDI bb85e36c-d3de-4bcb-9c55-178bd9f5da07 35 fields · synced May 30, 2026
  • FDA UDI 141585b7-42a0-407e-a2e6-1a03e81a3bff 35 fields · synced May 30, 2026
  • FDA UDI 935e4fd4-dcfd-4e8b-8ec5-485c55f5511e 35 fields · synced May 30, 2026
  • FDA UDI e7ebbfbc-8638-4c92-8b14-01a716c16577 36 fields · synced May 30, 2026
  • FDA UDI 60c636a6-c46e-4a56-bf11-bad78b88f9ea 36 fields · synced May 30, 2026
  • FDA UDI 0e0c0351-4750-4267-94ec-8cdf6466b06d 35 fields · synced May 30, 2026
  • FDA UDI 6e7ea8ec-b025-455a-9f63-f9fa68818031 35 fields · synced May 30, 2026
  • FDA UDI a030bccc-f204-4948-b098-fb4e06d851ee 35 fields · synced May 30, 2026
  • FDA UDI da563c91-0f11-46ec-89a6-9434c42b8a88 35 fields · synced May 30, 2026
  • FDA UDI 143f2cb1-350b-4bb1-9d26-13d68605b41f 35 fields · synced May 30, 2026
  • FDA UDI feacca40-c692-4084-bf76-bd90bdcf1df3 35 fields · synced May 30, 2026
  • FDA UDI 998cbbe8-6973-44bd-a829-147467e7b727 36 fields · synced May 30, 2026
  • EUDAMED 11398fbc-163c-4878-92ba-e0f24428179e 61 fields · synced Jul 10, 2026
  • EUDAMED 79a5e72e-6ac6-4b18-b562-9c46f86ebfd1 61 fields · synced Jul 11, 2026
  • EUDAMED caae3fc2-29f9-43cb-ab8d-61780c322b1d 61 fields · synced Jul 11, 2026
  • EUDAMED 54c33d43-c942-4576-a036-81f70928beed 61 fields · synced Jul 13, 2026
  • EUDAMED 8fd0fd77-bf3f-43a7-9258-fc3f8b25cf82 61 fields · synced Jul 13, 2026
  • EUDAMED e529b231-a954-4ad1-b3e7-c7b18b87e637 61 fields · synced Jul 13, 2026
  • EUDAMED ec6d24e2-90cc-4038-80fd-7c77a792b8dc 61 fields · synced Jul 13, 2026
  • EUDAMED 6b1703a6-d8ac-449d-b9e4-fc49ef6b9f80 61 fields · synced Jul 15, 2026
  • EUDAMED 817ef54e-6bc0-4a06-a9b5-5c6ec7513033 61 fields · synced Jul 18, 2026
  • EUDAMED 484f64c8-423f-4703-8228-de1e7e4fdf3a 61 fields · synced Jul 18, 2026
  • EUDAMED 0c458ca1-ba94-46ac-a107-88f62bbd0625 61 fields · synced Jul 19, 2026
  • EUDAMED 931930b1-61d9-4336-b872-feb4ebb2a958 61 fields · synced Jul 20, 2026
  • EUDAMED fbb6bfa4-d244-466c-be28-57c1b5913c7c 61 fields · synced Jul 21, 2026
  • EUDAMED ff508582-5f1a-4564-b4c2-577828e06ed7 61 fields · synced Aug 2, 2026
  • EUDAMED f8103f12-2c2a-47ba-8038-2f768baf20c8 61 fields · synced Aug 4, 2026
  • EUDAMED 8b11c9ca-2916-48a2-b1ea-7d8b583ed6e1 61 fields · synced Sep 18, 2026