FDA.reportPublic FDA data

SurgiLock

Primary DI
00850047863829
Brand
SurgiLock
Company
Medicalock Corporation
Model
Lateral Lumbar Interbody Fusion Kit
Catalog number
SLFLLIFK
Device description
Arm Bolster, Angled Leg Pad 4" thick - No Gel, Loading Base 3" thick w/ Elastak, Anterior Thoracic Pad 3" thick w/ Elastak, Arm Pad 6" x 24" x 1" w/ Elastak, Anterior Pelvic Pad, 3" thick w/ Elastak, Posterior Thoracic Pad, 3" thick w/ Elastak, Posterior Lumbar Pad, 3" thick w/ Elastak, 3 in 1 Deep Head Positioner w/ Elastak, Traction Base, 1" thick w/ Elastak, Strap Pad 3" x 24" x 0.25" w/ Elastak, Two-Way Face Strap 2" x 60" w/ 4" Bullet Nose Hook Tips
Published
2026-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCXSupport, Patient Position

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850047863829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850047863829008500478638298500478638290850047863829

Contacts#

Phone, Email table
PhoneEmail
6084302475jodie@medicalock.com

Regulatory Flags#

DUNS number
118863171
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850047863799SurgiLockAnterior Cervical Discectomy Fusion Positioning KiSLFACDFK2026-09-24
00850047863836CerviLockCerviLock Strap Kit w/ FoamCLSK-F2026-09-24
00850047863294SurgiLockLateral Thoracic KitSLFLTK2024-07-30
00850047863300SurgiLockGeneral Surgical Positioning KitSLFSHTPSPK2024-07-30
00850047863225SurgiLock"59"" Strap Pad"SLFPE59082024-07-30
00850047863621SurgiLockHeel Positioner SLFHEEL47K2025-12-01
00850047863317SurgiLockJelly Wrap Positioning Kit SLFJW1226K2024-07-30
00850047863515SurgiLock"20"" x 36"" Torso Pad"SLFPE20362025-03-27
00850047863454SurgiLockRobotics Positioning KitSLFSHTPJWK2025-02-11
00850047863287SurgiLock"20"" x 24"" Torso Pad (one side)"SLFP1E20242024-10-10
00850047863188SurgiLock"8"" x 10"" Pad"SLFPE08102024-10-10
00850047863218SurgiLock"24"" x 6"" Pad"SLFPE24062024-10-10
00850047863133Dentistry LockDentistry Lock PadDLP07552024-08-05
00850047863119SurgiLockSL10072024-07-30
00850047863102SurgiLockSL10072024-07-30
00850047863157SurgiLock3 in 1 Head PositionerSLFHPE312024-07-30
00850047863195SurgiLock"20"" x 24"" Torso Pad"SLFPE20242024-07-30
00850047863201SurgiLock"20"" x 29"" Torso Pad"SLFPE20292024-07-30
00850047863232SurgiLockTapered Leg PadSLFTLPE32142024-07-30
00850047863249SurgiLockStandard Head PositionerSLFHPES2024-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00696588008417ULP Precise™Innovative Medical Products, IncCCX2026-11-05
00696588008424ULP Precise™Innovative Medical Products, IncCCX2026-11-05
00696588008431ULP Precise™Innovative Medical Products, IncCCX2026-11-05
00696588008448ULP Precise™Innovative Medical Products, IncCCX2026-11-05
00696588008455ULP Precise™Innovative Medical Products, IncCCX2026-11-05
05060624129049Face Cushy Set (Helmet + Mirror)CARE SURGICAL LIMITEDCCX2026-11-03
00787551041668LPK10037 Lateral Positioning KitXODUS MEDICAL, INC.CCX2026-10-19
00787551041675LPK10036 Lateral Positioning KitXODUS MEDICAL, INC.CCX2026-10-19
00787551041682SPK10756 Surgical BackPack KitXODUS MEDICAL, INC.CCX2026-10-19
00860003986844GENESIS BI-WING XL GEN 3.0Infinitus Medical Technologies LLCCCX2026-10-15
00860014205507PNEUMA GENESIS BI-WIUNG POSITIONING SYSTEMInfinitus Medical Technologies LLCCCX2026-10-15
09421905187794Adept Medical Lateral Support SingleADEPT MEDICAL LIMITEDCCX2026-10-05
09421905187800Adept Medical Lateral Support PairADEPT MEDICAL LIMITEDCCX2026-10-05
09421905187817Adept Medical Lateral Vacuum BraceADEPT MEDICAL LIMITEDCCX2026-10-05
15060797554775NADavid Scott CompanyCCX2026-09-25
00850047863799SurgiLockMedicalock CorporationCCX2026-09-24
00850047863836CerviLockMedicalock CorporationCCX2026-09-24
00749756401739DeRoyalDEROYAL INDUSTRIES, INC.CCX2026-09-18
00848530109783Oxygen AccessorySunset Healthcare Solutions, Inc.CCX2026-09-09
00787551041637SPK11761 Jackson Table KitXODUS MEDICAL, INC.CCX2026-07-27
00787551041644SPK11773 Surgical BackPack KitXODUS MEDICAL, INC.CCX2026-07-27
00787551041651SPK11774 Surgical BackPack KitXODUS MEDICAL, INC.CCX2026-07-27
00851440007902Responsive Respiratory, Inc.RESPONSIVE RESPIRATORY, INC.CCX2026-07-22
00811836030907TrenGuard™Dan Allen Surgical LLCCCX2026-06-26
00811836030921TrenGuard™Dan Allen Surgical LLCCCX2026-06-26
20811836030215TrenGuard™Dan Allen Surgical LLCCCX2026-06-26
00860014205514TruBlu HDP BootlinersInfinitus Medical Technologies LLCCCX2026-06-05
00860014205521TruBlu HDP, Smith+Nephew Hip Positioning SystemInfinitus Medical Technologies LLCCCX2026-06-05
00860014205538TruBlu HDP, Hana Hip Positioning SystemInfinitus Medical Technologies LLCCCX2026-06-05
00814247021304Panniculus Retraction KitCLINICAL INNOVATIONS, LLCCCX2026-05-31