FDA.reportPublic FDA data

Subtalar implant, non-bioabsorbable, sterile

Definition
A sterile device designed to be implanted into the calcaneus bone or sinus tarsi of the foot to stabilize the subtalar/talotarsal joint to treat a hyperpronated foot (inward rotation during gait) and sequelae (e.g., flat foot) or other heel/arch abnormalities. It is a non-bioabsorbable device typically made of a metal (e.g., titanium alloy) or polyethylene (PE).
GUDID devices
87
Last updated
2021-10-26 08:20:46

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
M621HYP050HyProCure Size 05Graham Medical Technologies, L.L.C.HYP-052017-04-04
M621HYP060HyProCure Size 06Graham Medical Technologies, L.L.C.HYP-062017-04-04
M621HYP070HyProCure Size 07Graham Medical Technologies, L.L.C.HYP-072017-04-04
M621HYP080HyProCure Size 08Graham Medical Technologies, L.L.C.HYP-082017-04-04
M621HYP090HyProCure Size 09Graham Medical Technologies, L.L.C.HYP-092017-04-04
M621HYP100HyProCure Size 10Graham Medical Technologies, L.L.C.HYP-102017-04-04
M621HYPII060HyProCure II Sinus Tarsi Stent Size 06Graham Medical Technologies, L.L.C.HYP II-062017-02-09
M621HYPII070HyProCure II Sinus Tarsi Stent Size 07Graham Medical Technologies, L.L.C.HYP II-072017-04-04
M621HYPII080HyProCure II Sinus Tarsi Stent Size 08Graham Medical Technologies, L.L.C.HYP II-082017-04-04
M621HYPII090HyProCure II Sinus Tarsi Stent Size 09Graham Medical Technologies, L.L.C.HYP II-092017-04-04
M621HYPII100HyProCure II Sinus Tarsi Stent Size 10Graham Medical Technologies, L.L.C.HYP II-102017-04-04
M621HYPII110HyProCure II Sinus Tarsi Stent Size 11Graham Medical Technologies, L.L.C.HYP II-112017-04-04
M621HYPII120HyProCure II Sinus Tarsi Stent Size 12Graham Medical Technologies, L.L.C.HYP II-122017-04-04
00810012480291HORIZON TITANIUM SUBTALAR 8MMBIOPRO, INC.172212021-06-14
00810012480307HORIZON TITANIUM SUBTALAR 9MMBIOPRO, INC.172222021-06-14
00810012480314HORIZON TITANIUM SUBTALAR 10MMBIOPRO, INC.172232021-06-14
00810012480321HORIZON TITANIUM SUBTALAR 11MMBIOPRO, INC.172242021-06-14
00810012480338HORIZON TITANIUM SUBTALAR 12MMBIOPRO, INC.172252021-06-14
00810012480345HORIZON TITANIUM SUBTALAR 6MMBIOPRO, INC.174782021-06-14
M248MBASET1MBA™Ascension Orthopedics, Inc.MBASET2016-07-25
M248MBAIMP1MBA™ Titanium Subtalar Implant SystemAscension Orthopedics, Inc.MBAIMP2018-05-11
M2480400080bioBLOCK® Subtalar Implant SystemINTEGRA LIFESCIENCES CORPORATION0400082017-10-09
M2480400090bioBLOCK® Subtalar Implant SystemINTEGRA LIFESCIENCES CORPORATION0400092017-10-09
M2480400100bioBLOCK® Subtalar Implant SystemINTEGRA LIFESCIENCES CORPORATION0400102017-10-09
M2480400110bioBLOCK® Subtalar Implant SystemINTEGRA LIFESCIENCES CORPORATION0400112017-10-09
M2480400120bioBLOCK® Subtalar Implant SystemINTEGRA LIFESCIENCES CORPORATION400122017-10-09
M2480501061MBA™ Titanium Subtalar Implant SystemINTEGRA LIFESCIENCES CORPORATION0501062017-10-09
M2480501081MBA™ Titanium Subtalar Implant SystemINTEGRA LIFESCIENCES CORPORATION0501082017-10-09
M2480501091MBA™ Titanium Subtalar Implant SystemINTEGRA LIFESCIENCES CORPORATION0501092017-10-09
M2480501101MBA™ Titanium Subtalar Implant SystemINTEGRA LIFESCIENCES CORPORATION0501102017-10-09
M2480501121MBA™ Titanium Subtalar Implant SystemINTEGRA LIFESCIENCES CORPORATION0501122017-10-09
10815375021065Sub-Talar LokRestore Surgical LLCST50072015-10-17
10815375021072Sub-Talar LokRestore Surgical LLCST50082015-10-17
10815375021089Sub-Talar LokRestore Surgical LLCST50092015-10-17
10815375021096Sub-Talar LokRestore Surgical LLCST50102015-10-17
10815375021102Sub-Talar LokRestore Surgical LLCST50112015-10-17
00819034029501LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCSG-LD-0001-S2020-11-24
00819034029518LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCSG-LD-0501-S2020-11-24
00819034029525LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCSG-LD-0002-S2020-11-24
00819034029532LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCSG-LD-0502-S2020-11-24
00819034029549LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCSG-LD-0003-S2020-11-24
00819034029556LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCSG-LD-0503-S2020-11-24
00840124500648PolyLockFUSION ORTHOPEDICS, LLCSB-NL-27142020-11-24
00840124500716PolyLockFUSION ORTHOPEDICS, LLCSB-NL-27282020-11-24
M20922642HORIZON SUBTALAR GEN 2 6MMBIOPRO, INC.226422020-09-23
M20922643Horizon Subtalar Gen 2 7mmBIOPRO, INC.226432020-09-23
M20922644HORIZON SUBTALAR GEN 2 8MMBIOPRO, INC.226442020-09-23
M20922645HORIZON SUBTALAR GEN 2 9MMBIOPRO, INC.226452020-09-23
M20922646HORIZON SUBTALAR GEN 2 10MMBIOPRO, INC.226462020-09-23
M20922647HORIZON SUBTALAR GEN 2 11MMBIOPRO, INC.226472020-09-23
M20922648HORIZON SUBTALAR GEN 212MMBIOPRO, INC.226482020-09-23
M268TRUARCHIMP1Integra® TruArch®Ascension Orthopedics, Inc.TRUARCHIMP2015-09-22
00840420128881BIOARCHWRIGHT MEDICAL TECHNOLOGY, INC.ST11082015-10-01
00840420128898BIOARCHWRIGHT MEDICAL TECHNOLOGY, INC.ST11092015-10-01
00840420128904BIOARCHWRIGHT MEDICAL TECHNOLOGY, INC.ST11102015-10-01
00840420128911BIOARCHWRIGHT MEDICAL TECHNOLOGY, INC.ST11112015-10-01
00840420128928BIOARCHWRIGHT MEDICAL TECHNOLOGY, INC.ST11122015-10-01
00840420132482STA-PEGWRIGHT MEDICAL TECHNOLOGY, INC.210000012015-10-01
00840420132499STA-PEGWRIGHT MEDICAL TECHNOLOGY, INC.210000022015-10-01
00840420132505STA-PEGWRIGHT MEDICAL TECHNOLOGY, INC.210001112015-10-01
00840420132512STA-PEGWRIGHT MEDICAL TECHNOLOGY, INC.210001122015-09-23
00840420132529STA-PEGWRIGHT MEDICAL TECHNOLOGY, INC.210001132015-10-01
00840420169402SUBTALAR SPACER SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.01-0062015-10-01
00840420169419SUBTALAR SPACER SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.01-0072015-10-01
00840420169426SUBTALAR SPACER SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.01-0082015-10-01
00840420169433SUBTALAR SPACER SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.01-0092015-10-01
00840420169440SUBTALAR SPACER SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.01-0102015-10-01
00840420169457SUBTALAR SPACER SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.01-0112015-10-01
00840420169471SUBTALAR SPACER SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.03-0072015-10-01
00840420169488SUBTALAR SPACER SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.03-0082015-10-01
00840420169495SUBTALAR SPACER SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.03-0092015-10-01
00840420169501SUBTALAR SPACER SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.03-0102015-10-01
00840420169518SUBTALAR SPACER SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.03-0112015-10-01
00840420170637GAITWAYWRIGHT MEDICAL TECHNOLOGY, INC.30-100-022015-10-15
00842528110881OsteoMedOSTEOMED LLC341-10132019-01-08
008129260202357mm Twist Subtalar ImplantTrilliant Surgical, LLC102-10-0072017-01-26
008129260202428mm Twist Subtalar ImplantTrilliant Surgical, LLC102-10-0082017-01-27
008129260202599mm Twist Subtalar ImplantTrilliant Surgical, LLC102-10-0092017-01-27
0081292602026610mm Twist Subtalar ImplantTrilliant Surgical, LLC102-10-0102017-01-27
0081292602027311mm Twist Subtalar ImplantTrilliant Surgical, LLC102-10-0112017-01-27